The Impact of the Pharmaceutical Care Management Model of Hepatitis C Medications on the Cost at Health Insurance Level.

OBJECTIVE: The aim of this study is to evaluate the impact of adopting a pharmaceutical care model on clinical outcomes, patient satisfaction, and cost at a health payer level. METHODS: All patients with hepatitis C virus (HCV) who were insured by Bupa Arabia, with a direct-acting antivirals prior authorization drug request between April 2015 and October 2018 were included in this retrospective quasi-experimental study. The clinical outcome was the achievement of a sustained virologic response at least 12 weeks from end of treatment. Economic and patients' satisfaction outcomes were included in this study. The differences in cost of treatment was analyzed by using the paired t test. Stata statistical software package (StataCorp, College Station, TX) was used for data analysis. RESULTS: A total of 371 patients were enrolled in this program of which 74% (n = 273) required clinical intervention. Among those, HCV treatment was modified for 64%. The overall cure rate was 97% among 267 patients for which sustained virologic responses were available. The results of the paired t test show that there was a 38% reduction in the mean direct cost of medications before and after intervention (95% confidence interval, 33%-43%; P<.001) and the calculated patients' satisfaction was 98%. CONCLUSIONS: A structured pharmaceutical care program for HCV patients can guide the use of specialty medications to achieve optimal clinical outcomes, with lower expenditures and high patients' satisfaction. We can conclude that healthcare insurance can play a key role in managing specialty pharmaceuticals like HCV medications. Because this is a preliminary study, further studies are needed in an experimental design to strengthen the evidence behind the effectiveness of such a program.

Effectiveness of step therapy policies for specialty pharmaceuticals in immune disorders.

OBJECTIVE: To assess the effectiveness of managed care plans that limited access to infusion biologics via a step therapy policy. STUDY DESIGN: This was a retrospective cohort study using Symphony Health Solutions claims databases that included payer, prescription (Rx), diagnosis (Dx) and procedure (Px) information with unique anonymized patient identifiers. METHODS: The percentage of patients with claims for infusion and subcutaneous (SQ) biologics were evaluated across three increasingly restrictive cohorts: (1) patients in step therapy plans versus all others in the database (population), (2) patients in step therapy plans versus patients that were members of plans that were roughly matched (matched) and (3) a subsample of patients that were members of step therapy plans that had sufficient data for a pre/post analysis (pre/post). RESULTS: The population analysis comparison showed 5.1% fewer patients (p < 0.0001) with claims for infusion biologics among step therapy plans than among the overall plans. The more controlled matched and pre/post analyses showed a greater percentage of patients with claims for intravenous products in the plans with step therapy policies versus plans without step therapy policies, differences of +7.0% (p < 0.0001) and +2.8% (p = 0.0522), respectively. CONCLUSIONS: Policies designed to limit utilization of infusion biologics showed equivocal results. In the near term, the intended effects of implementing step therapy policies may be limited by relatively small numbers of patients that are affected relative to the total number of users.

Breaking the Bank: Three Financing Models for Addressing the Drug Innovation Cost Crisis.

BACKGROUND: The introduction of innovative specialty pharmaceuticals with high prices has renewed efforts by public and private healthcare payers to constrain their utilization, increase patient cost-sharing, and compel government intervention on pricing. These efforts, although rational for individual payers, have the potential to undermine the public health impact and overall economic value of these innovations for society. The emerging archetypal example is the outcry over the cost of sofosbuvir, a drug proved to cure hepatitis C infection at a cost of $84,000 per person for a course of treatment (or $1000 per tablet). This represents a radical medical breakthrough for public health, with great promise for the long-term costs associated with this disease, but with major short-term cost implications for the budgets of healthcare payers. OBJECTIVES: To propose potential financing models to provide a workable and lasting solution that directly addresses the misalignment of incentives between healthcare payers confronted with the high upfront costs of innovative specialty drugs and the rest of the US healthcare system, and to articulate these in the context of the historic struggle over paying for innovation. DISCUSSION: We describe 3 innovative financing models to manage expensive specialty drugs that will significantly reduce the direct, immediate cost burden of these drugs to public and private healthcare payers. The 3 financing models include high-cost drug mortgages, high-cost drugs reinsurance, and high-cost drug patient rebates. These models have been proved successful in other areas and should be adopted into healthcare to mitigate the high-cost of specialty drugs. We discuss the distribution of this burden over time and across the healthcare system, and we match the financial burden of medical innovations to the healthcare stakeholders who capture their overall value. All 3 models work within or replicate the current healthcare marketplace mechanisms for distributing immediate high-cost events across multiple at-risk stakeholders, and/or encouraging active participation by patients as consumers. CONCLUSION: The adoption of these 3 models for the financing of high-cost drugs would ameliorate decades-long economic conflict in the healthcare system over the value of, and financial responsibility for, drug innovation.

The impact of specialty pharmaceuticals as drivers of health care costs.

The pharmaceutical industry is shifting its focus from blockbuster small molecules to specialty pharmaceuticals. Specialty pharmaceuticals are novel drugs and biologic agents that require special handling and ongoing monitoring, are administered by injection or infusion, and are sold in the marketplace by a small number of distributors. They are frequently identified by having a cost to payers and patients of $600 or more per treatment. The total costs of the new agents are likely to have a substantial impact on overall health care costs and on patients during the next decade, unless steps are taken to align competing interests. We examine the economic and policy issues related to specialty pharmaceuticals, taking care to consider the impact on patients. We assess the role of cost-sharing provisions, legislation that is promoting realignment within the market, the role of biosimilars in price competition, and the potential for novel drug development paradigms to help bend the cost curve. The economic aspects of this analysis highlight the need for a far-reaching discussion of potential novel approaches to innovation pathways in our quest for both affordability and new technology.

Biosimilars: a cure to the U.S. health care cost conundrum?

As the cost of healthcare continues to rise and patents on biologics near expiration, biosimilars are gaining visibility as a mechanism for cost reduction. Yet, the introduction of biosimilars into the U.S. market will be complex, due to the related complexity of production, research requirements, and regulatory uncertainty. The purpose of this paper is to frame the relevant issues in order to provide context for stakeholders. It is particularly crucial that clinicians understand the scientific, regulatory, legislative and economic considerations involved in order to ensure that the path to approval is consistent with their needs and that appropriate utilization occurs, once approved.