Medicare Coverage and Patient Out-of-Pocket Costs for Cardiovascular-Kidney-Metabolic Medications.

This cross-sectional study evaluates the association between Medicare coverage and patient out-of-pocket costs for cardiovascular-kidney-metabolic medications.

Medication adherence in cardiovascular medicine.

Cardiovascular disease is the leading cause of death globally. While pharmacological advancements have improved the morbidity and mortality associated with cardiovascular disease, non-adherence to prescribed treatment remains a significant barrier to improved patient outcomes. A variety of strategies to improve medication adherence have been tested in clinical trials, and include the following categories: improving patient education, implementing medication reminders, testing cognitive behavioral interventions, reducing medication costs, utilizing healthcare team members, and streamlining medication dosing regimens. In this review, we describe specific trials within each of these categories and highlight the impact of each on medication adherence. We also examine ongoing trials and future lines of inquiry for improving medication adherence in patients with cardiovascular diseases.

Evaluation of availability, price, and affordability of cardiovascular, diabetes, and global medicines in Abuja, Nigeria.

OBJECTIVE: To assess the availability, price, and affordability of cardiovascular, diabetes, and global medicines in Abuja, Nigeria. METHODS: A cross-sectional survey involving 27 private pharmacies, 13 public pharmacies, and 25 private hospital pharmacies in Abuja was conducted using the standardized World Health Organization/Health Action International methodology. The availability percentage for each pharmacy sector and each medicine was analyzed. The median price ratio (MPR) (ratio of the median price to the international reference prices) of the medicines were evaluated accordingly. Affordability was assessed by calculating the number of days' wages the lowest-paid unskilled government worker required to purchase a month worth of the standard treatment for a chronic condition. RESULTS: The availability of cardiovascular (CV) medicines ranged from 28.4% (in private hospital pharmacies) to 59.9% (in private pharmacies). There was mixed variability in the mean availability of Originator Brands (OBs) and Lowest Priced Generics (LPGs) anti-diabetic drugs with the highest availability being OBs 36% and LPGs 40.2%, in private pharmacies and public pharmacies, respectively. The availability of global drugs ranged from 49.7% in private hospitals to 68.8% in private pharmacies. Two cardiovascular and four global medicines had greater than 80% availability across the pharmaceutical sectors. The median price ratio for OBs and LPGs was 9.60 and 1.72 for procurement, it was 8.08 and 2.60 in private pharmacies, 13.56 and 2.66 in public hospitals, and 16.38 and 7.89 in private hospitals. The percentage markup on LPG was 49.4% in public hospitals, 51.4% in private pharmacies, and 323% in private hospitals. Only nine medicines in both public hospitals and private pharmacies and two in the private hospital pharmacies required less than the daily wage of the lowest-paid government worker. CONCLUSION: The availability of cardiovascular, diabetes, and global medicines was below 80% across the different pharmaceutical sectors in Abuja and the medicines were unaffordable. Although the prices were generally exorbitant, private pharmacies offered the best options in terms of availability, pricing, and affordability of medicines. Therefore, the results of this study emphasize the pertinence of enforcing policies that facilitate the availability, pricing, and affordability of cardiovascular, diabetes, and global medicines.

Associations between essential medicines and health outcomes for cardiovascular disease.

BACKGROUND: National essential medicines lists are used to guide medicine reimbursement and public sector medicine procurement for many countries therefore medicine listings may impact health outcomes. METHODS: Countries' national essential medicines lists were scored on whether they listed proven medicines for ischemic heart disease, cerebrovascular disease and hypertensive heart disease. In this cross sectional study linear regression was used to measure the association between countries' medicine coverage scores and healthcare access and quality scores. RESULTS: There was an association between healthcare access and quality scores and health expenditure for ischemic heart disease (p ≤ 0.001), cerebrovascular disease (p ≤ 0.001) and hypertensive heart disease (p ≤ 0.001). However, there was no association between medicine coverage scores and healthcare access and quality scores for ischemic heart disease (p = 0.252), cerebrovascular disease (p = 0.194) and hypertensive heart disease (p = 0.209) when country characteristics were accounted for. CONCLUSIONS: Listing more medicines on national essential medicines lists may only be one factor in reducing mortality from cardiovascular disease and improving healthcare access and quality scores.

Strategies to Reduce Out-of-Pocket Medication Costs for Canadians Living with Heart Failure.

INTRODUCTION: Daily medication is the cornerstone of evidence-based therapy to reduce mortality and morbidity in patients with heart failure (HF). Up to 20% of Canadian patients pay for medications out of pocket. We sought to identify strategies that patients and prescribers can employ to reduce these costs. METHODS: We collected data from outpatient pharmacies in Hamilton, Ontario. We determined prices for different medications in each of the drug classes recommended for HF with reduced ejection fraction in the Canadian Cardiovascular Society's guidelines. We examined differences in dispensing and delivery fees and inquired about other cost-saving strategies. RESULTS: We collected data from 24 different pharmacies, including a selection of hospital-based, independent, and larger chain pharmacies. In the most extreme scenario (i.e., 90-day prescription instead of a 30-day prescription and the least expensive generic drug instead of the most expensive brand name drug), total medication costs can differ by up to $495.56 per month. Costs were affected by choice of agent within a drug class, generic versus brand-name drug, quantity dispensed, dispensing fee, and delivery cost. CONCLUSIONS: Prescription content, dispensing practice, and pharmacy choice can remarkably impact out-of-pocket costs for HF medications. Prescribers can reduce costs by writing 90-day prescriptions and choosing the lowest-cost generic drugs in each therapeutic class. Patients should consider the services received for their pharmacy dispensing fees, use free delivery services where needed, and request inexpensive generic drugs. Pharmacists can facilitate cost minimization without compromising therapeutic efficacy.

Ivabradine as adjuvant treatment for chronic heart failure.

BACKGROUND: Chronic heart failure is one of the most common medical conditions, affecting more than 23 million people worldwide. Despite established guideline-based, multidrug pharmacotherapy, chronic heart failure is still the cause of frequent hospitalisation, and about 50% die within five years of diagnosis. OBJECTIVES: To assess the effectiveness and safety of ivabradine in individuals with chronic heart failure. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, and CPCI-S Web of Science in March 2020. We also searched ClinicalTrials.gov and the WHO ICTRP. We checked reference lists of included studies. We did not apply any time or language restrictions. SELECTION CRITERIA: We included randomised controlled trials in which adult participants diagnosed with chronic heart failure were randomly assigned to receive either ivabradine or placebo/usual care/no treatment. We distinguished between type of heart failure (heart failure with a reduced ejection fraction or heart failure with a preserved ejection fraction) as well as between duration of ivabradine treatment (short term (< 6 months) or long term (≥ 6 months)). DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion, extracted data, and checked data for accuracy. We calculated risk ratios (RR) using a random-effects model. We completed a comprehensive 'Risk of bias' assessment for all studies. We contacted authors for missing data. Our primary endpoints were: mortality from cardiovascular causes; quality of life; time to first hospitalisation for heart failure during follow-up; and number of days spent in hospital due to heart failure during follow-up. Our secondary endpoints were: rate of serious adverse events; exercise capacity; and economic costs (narrative report). We assessed the certainty of the evidence applying the GRADE methodology. MAIN RESULTS: We included 19 studies (76 reports) involving a total of 19,628 participants (mean age 60.76 years, 69% male). However, few studies contributed data to meta-analyses due to inconsistency in trial design (type of heart failure) and outcome reporting and measurement. In general, risk of bias varied from low to high across the included studies, with insufficient detail provided to inform judgement in several cases. We were able to perform two meta-analyses focusing on participants with heart failure with a reduced ejection fraction (HFrEF) and long-term ivabradine treatment. There was evidence of no difference between ivabradine and placebo/usual care/no treatment for mortality from cardiovascular causes (RR 0.99, 95% confidence interval (CI) 0.88 to 1.11; 3 studies; 17,676 participants; I2 = 33%; moderate-certainty evidence). Furthermore, we found evidence of no difference in rate of serious adverse events amongst HFrEF participants randomised to receive long-term ivabradine compared with those randomised to placebo, usual care, or no treatment (RR 0.96, 95% CI 0.92 to 1.00; 2 studies; 17,399 participants; I2 = 12%; moderate-certainty evidence). We were not able to perform meta-analysis for all other outcomes, and have low confidence in the findings based on the individual studies. AUTHORS' CONCLUSIONS: We found evidence of no difference in cardiovascular mortality and serious adverse events between long-term treatment with ivabradine and placebo/usual care/no treatment in participants with heart failure with HFrEF. Nevertheless, due to indirectness (male predominance), the certainty of the available evidence is rated as moderate.

Heart Failure and Shared Decision-Making: Patients Open to Medication-Related Cost Discussions.

BACKGROUND: Discussions of medication costs between patients and clinicians are infrequent and often suboptimal. In the context of recently introduced drugs that are effective but expensive, patients with heart failure with reduced ejection fraction provide an ideal population to understand the perspectives of patients with chronic illness on medication cost and cost discussions. METHODS: To explore patients' perspectives on discussing out-of-pocket medication costs with clinicians, 49 adults, aged 44 to 70 years, with heart failure with reduced ejection fraction were recruited from outpatient heart failure clinics. Descriptive qualitative analysis was performed on open-ended text data. RESULTS: Participants who had prior medication-related cost discussions described their experience as generally positive, but about half of the participants had never had a cost discussion with their clinician. Most participants were open to cost discussions with clinicians and preferred that the clinician initiate discussions regarding medication cost. Importantly, these preferences held constant across reported levels of financial burden. CONCLUSIONS: These data suggest a substantial willingness on the part of patients with heart failure with reduced ejection fraction to incorporate cost discussions into their care and identify important aspects of these discussions for clinicians to consider when engaging in conversations where cost is relevant. Improving understanding about how to integrate patient preferences regarding cost discussions into clinical encounters is an important priority for advancing patient-centered care.

Availability, price and affordability of essential medicines for managing cardiovascular diseases and diabetes: a statewide survey in Kerala, India.

OBJECTIVE: Limited access to essential medicines (EMs) for cardiovascular disease (CVD) and diabetes is a major concern in low- and middle-income countries. We aimed to generate data on availability, price and affordability of EMs for CVD and diabetes in India. METHODS: Using WHO/HAI survey methodology, we evaluated availability and prices of 23 EMs in 30 public sector facilities (government hospitals and semi-public/government-subsidised-discount-pharmacies (GSDPs)) and 60 private retail pharmacies across six districts in Kerala state, India (November 2018 - May 2019). Median Price Ratios (MPRs) were calculated by comparing consumer prices with international reference prices. We also analysed data (collected in July 2020) on six anti-hypertensive fixed-dose-combinations (FDCs) that were designated as 'essential' by the WHO in 2019. RESULTS: Mean availability of surveyed generic EMs was 45.7% in government hospitals, 64.7% in GSDPs and 72.0% in private retail pharmacies. On average, the most-sold and highest-priced generics, respectively, were 6.6% and 8.9% costlier than the lowest-priced generics (LPG). Median MPR for LPG was 2.71 in private retail and 2.25 in GSDPs. Monthly supply of LPG would cost the lowest-paid worker 1.11 and 0.79 days' wages in private retail and GSDPs, respectively. Mean availability of the surveyed FDCs was poor (private retail: 15-85%; GSDPs: 8.3-66.7%), and the private retail prices of FDCs were comparable to the sum of corresponding constituent monotherapies. CONCLUSION: Availability of CVD and diabetes EMs fall short of WHO's 80% target in both sectors. Although availability in the private retail pharmacies was near-optimal, prices appear unaffordable compared to GSDPs. Initiatives such as mandating generic prescribing, adding the WHO-approved FDCs in local EM lists, improving price transparency, and streamlining medicine supply to ensure equitable access to EMs, especially in the public sector, are crucial in tackling Kerala's ever-increasing CVD burden.

OBJECTIF: L'accès limité aux médicaments essentiels (ME) pour les maladies cardiovasculaires (MCV) et le diabète est une préoccupation majeure dans les pays à revenu faible et intermédiaire. Nous visions à générer des données sur la disponibilité, le prix et l'aspect abordable des ME pour les MCV et le diabète en Inde. MÉTHODES: En utilisant la méthodologie OMS/HAI, nous avons évalué la disponibilité et les prix de 23 ME dans 30 établissements du secteur public (hôpitaux publics et pharmacies semi-publiques/à discompte subventionnées par le gouvernement (GSDP)) et 60 pharmacies de détail privées dans 6 districts de l'Etat du Kerala, en Inde. Les ratios de prix médians (RPM) ont été calculés en comparant les prix des consommateurs aux prix de référence internationaux. Nous avons également analysé les données de six combinaisons à dose fixe (CDF) d'antihypertensives désignées ''essentielles'' par l'OMS en 2019. RÉSULTATS: La disponibilité moyenne des ME génériques étudiés était de 45,7% dans les hôpitaux publics, de 64,7% dans les GSDP et de 72,0% dans le commerce de détail privé. En moyenne, les génériques les plus vendus et les plus chers, respectivement, étaient de 6,6% et 8,9% plus chers que les génériques les moins chers (GMC). Le RPM pour les (GMC) était de 2,71 dans le secteur privé et de 2,25 dans les GSDP. L'approvisionnement mensuel en GMC coûterait au travailleur le moins payé le salaire de 1,11 et 0,79 jour de travail dans le secteur de la vente au détail privé et dans les GSDP, respectivement. La disponibilité moyenne des CDF était faible (vente au détail privée: 15% - 85%; GSDP: 8,3%-66,7%), avec des prix de détail privés comparables à la somme des monothérapies constituantes correspondantes. CONCLUSION: La disponibilité des ME pour les MCV et le diabète est inférieure à l'objectif de 80% de l'OMS dans les deux secteurs. Bien que la disponibilité dans les pharmacies de détail privées soit presque optimale, les prix semblent inabordables par rapport aux GSDP. Des initiatives telles que la prescription de médicaments génériques, l'inscription des CDF sous ME, l'amélioration de la transparence des prix, la rationalisation de l'approvisionnement en médicaments pour assurer un accès équitable aux ME, en particulier dans le secteur public, sont essentielles pour faire face à la charge toujours croissante des MCV dans le Kerala.

New and emerging cardiovascular and antihypertensive drugs.

INTRODUCTION: Hypertension and cardiovascular diseases (CVD) are very common conditions and account for significant medical disability and death worldwide. Therefore, their successful management is very critical for the prevention of the significant cardiovascular and socioeconomic consequences arising from their poor management. Areas Covered: Although we have several effective cardiovascular (CV) drugs for their treatment, they are not all completely successful for the effective management of CVD and hypertension. Thus, the need for the discovery and development of new drugs is necessary. For this review, a Medline search of the English language was conducted between 2010 and June 2020 and 62 pertinent papers were retrieved. These papers contain information on newly released and emerging new cardiovascular drugs. EXPERT OPINION: These new chemical entities have different mechanisms of action and in preliminary studies have been successful in the treatment of hypertension, CVD, heart failure, stroke, and type 2 diabetes mellitus. These drugs can be used either alone or in combination with other antihypertensive and cardiovascular drugs. Hopefully, these new classes of cardiovascular drugs would be effective for the treatment of hypertension and CVD and decrease their socioeconomic consequences.

Long-Term (3 Years) Outcomes of Ranolazine Therapy for Refractory Angina Pectoris (from the Ranolazine Refractory Registry).

Ranolazine is approved for patients with chronic stable angina but has not been formally studied in patients with refractory angina pectoris (RAP). Patients with RAP have limited therapeutic options and significant limitations in their quality of life. The Ranolazine Refractory Angina Registry was designed to evaluate the safety, tolerability, and effectiveness of ranolazine in RAP patients in order to expand treatment options for this challenging patient population. Using an extensive prospective database, we enrolled 158 consecutive patients evaluated in a dedicated RAP clinic. Angina class, medications, major adverse cardiac events including death, myocardial infarction, and revascularization were obtained at 12, 24, and 36 months. At 3 years, 95 (60%) patients remained on ranolazine. A ≥2 class improvement in angina was seen in 48% (38 of 80 patients with known Canadian Cardiovascular Society class) of those who remained on ranolazine. Discontinuation due to side effects, ineffectiveness, cost, and progression of disease were the principle reasons for discontinuation, but primarily occurred within the first year. In conclusion, ranolazine is an effective antianginal therapy at 3-year follow-up in patients with RAP and may reduce cardiac readmission.

Impact of pharmaceutical price controls on the cost of cardiovascular drugs: does essentiality matter?

BACKGROUND: With the goal of improving the affordability of medicines, governments across the globe have instituted various forms of price controls. Since 2013, India has been regulating the prices of drugs included in its national list of essential medicines (NLEM). Here we evaluate the cost variations among available cardiovascular drugs and perform cost-analysis comparing essential and non-essential drugs. METHODS: Data on listed prices of selected cardiovascular drugs - essential (NLEM) and non-essential (NNLEM) - were sourced from multiple drug information compendia. Price of medications was calculated in cost-per-defined-daily-dose (DDD)-units and NLEM vs. NNLEM drugs were compared. Regression analysis was used to explore the determinants of percentage cost variation (PCV) of drugs. RESULTS: The median-cost/DDD of essential medicines was lower as compared to non-essential ones for all therapeutic drug classes, with greatest difference observed for antianginals and least for heart failure medicines. There were substantial cost variations with values in excess of 1000% for six medicines, all being essential. The regression analysis failed to demonstrate a significant effect of essentiality on PCV (ß = 0.19, P = 0.314). CONCLUSIONS: Our analyses demonstrate considerable cost variations for some essential cardiovascular medicines. Given the need for prolonged and often, lifelong-treatment, there is significant potential for cost savings based on chosen brand, highlighting the need for patient as well as prescriber education.

Relative Costs of Surgical and Transcatheter Aortic Valve Replacement and Medical Therapy.

BACKGROUND: The number of patients treated for aortic valve disease in the United States is increasing rapidly. Transcatheter aortic valve replacement (TAVR) is supplanting surgical aortic valve replacement (SAVR) and medical therapy (MT). The economic implications of these trends are unknown. Therefore, we undertook to determine the costs, inpatient days, and number of admissions associated with treating aortic valve disease with SAVR, TAVR, or MT. METHODS: Using the Nationwide Readmissions Database, we identified patients with aortic valve disease admitted 2012 to 2016 for SAVR, TAVR, and disease symptoms (congestive heart failure, unstable angina, non-ST-elevation myocardial infarction, syncope). Patients not undergoing SAVR or TAVR were classified as receiving MT. Beginning with the index admission, we estimated inpatient costs, days, and admissions over 6 months. RESULTS: Among 190 563 patients with aortic valve disease, the average aggregate 6-month inpatient costs were $59 743 for SAVR, $64 395 for TAVR, and $23 460 for MT. Mean index admission was longer for SAVR (10.0 days) than for TAVR (7.0 day) or MT (5.3 days), but the average number of unplanned readmission inpatient days was 2.0 for SAVR, 3.0 for TAVR, and 4.3 for MT; the average number of total admissions was 1.3 for SAVR, 1.5 for TAVR, and 1.7 for MT (P<0.01 for all). TAVR index admission costs decreased over time to become similar to SAVR costs by 2016. CONCLUSIONS: Aggregate costs were higher for TAVR than SAVR and were significantly more expensive than MT alone. However, TAVR costs decreased over time while SAVR and MT costs remained unchanged.

Danish National Trends in Cardiovascular Disease and Cancer Drug Expenditure in Relation to Trends in Cardiovascular Disease and Cancer Deaths.

BACKGROUND: Cancer and cardiovascular disease are the 2 leading causes of death in most developed countries, making up the majority of national health care expenditures. In this study, we investigated nationwide trends of cardiovascular disease and cancer drug expenditure in relation to concomitant trends in cardiovascular disease and cancer death rates. METHODS: We obtained cardiovascular and cancer drug expenditure data in Denmark through the Danish Register of Medical Product Statistics. Trends in cancer deaths and cardiovascular disease deaths were observed by linkage to the cancer statistics for the Nordic Countries and Danish Heart Foundation databases. RESULTS: Our data show that introduction and rapid uptake of generic versions of most cardiovascular disease drugs have resulted in a remarkable cost-neutral development in cardiovascular disease drug expenditure from 1995 to 2018 despite increased drug use. This development is contrasted to cancer drug expenditure, which has increased more than 15-fold in the same period. Since 2006, expenditure for cancer drugs has exceeded that for cardiovascular disease drugs and is now more than triple that cost. However, death rates for cancer have dropped a fraction as much as for cardiovascular disease. CONCLUSION: Our results point to a disproportionate high mortality-adjusted expenditure for cancer drugs compared to cardiovascular disease drugs and demonstrate an enormous potential for national health care savings when cheaper versions like biosimilars of many cancer drugs are introduced.

Access to Cardiovascular Disease and Hypertension Medicines in Developing Countries: An Analysis of Essential Medicine Lists, Price, Availability, and Affordability.

Background Access to medicines is important for long-term care of cardiovascular diseases and hypertension. This study provides a cross-country assessment of availability, prices, and affordability of cardiovascular disease and hypertension medicines to identify areas for improvement in access to medication treatment. Methods and Results We used the World Health Organization online repository of national essential medicines lists (EMLs) for 53 countries to transcribe the information on the inclusion of 12 cardiovascular disease/hypertension medications within each country's essential medicines list. Data on availability, price, and affordability were obtained from 84 surveys in 59 countries that used the World Health Organization's Health Action International survey methodology. We summarized and compared the indicators across lowest-price generic and originator brand medicines in the public and private sectors and by country income groups. The average availability of the select medications was 54% in low- and lower-middle-income countries and 60% in high- and upper-middle-income countries, and was higher for generic (61%) than brand medicines (41%). The average patient median price ratio was 80.3 for brand and 16.7 for generic medicines and was higher for patients in low- and lower-middle-income countries compared with high- and upper-middle-income countries across all medicine categories. The costs of 1 month's antihypertensive medications were, on average, 6.0 days' wage for brand medicine and 1.8 days' wage for generics. Affordability was lower in low- and lower-middle-income countries than high- and upper-middle-income countries for both brand and generic medications. Conclusions The availability and accessibility of pharmaceuticals is an ongoing challenge for health systems. Low availability and high costs are major barriers to the use of and adherence to essential cardiovascular disease and antihypertensive medications worldwide, particularly in low- and lower-middle-income countries.

Affordability Assessment from a Static to Dynamic Concept: A Scenario-Based Assessment of Cardiovascular Medicines.

The out-of-pocket payments for prescription medications can impose a financial burden on patients from low- and middle- incomes and who suffer from chronic diseases. The present study aims at evaluating the affordability of cardiovascular disease (CVD) medication in Iran. This includes measuring affordability through World Health Organization/Health Action International (WHO/HAI) methodology. In this method, affordability is characterized as the number of days' wages of the lowest-paid unskilled government worker. The different medication therapy scenarios are defined in mono-and combination therapy approaches. This method adds on to WHO/HAI methodology to discover new approaches to affordability assessments. The results show the differences in the medicines affordability when different approaches are used in mono-and combination therapy between 6 main sub-therapeutic groups of CVD. It indicates the medicine affordability is not a static concept and it changes dynamically between CVD therapeutic subgroups when it used alone or in combination with other medicines regarding patients' characteristics and medical conditions. Hypertension and anti-arrhythmia therapeutic groups had the most non-affordability and hyperlipidemia had the most affordable medicines. Therefore, affordability can be considered as a dynamic concept, which not only affected by the medicine price but significantly affected by a patient's characteristics, the number of medical conditions, and insurance coverage.