Cost-effectiveness of rimegepant oral lyophilisate compared to best supportive care for the acute treatment of migraine in the UK.

AIMS: Migraine is the most common disabling headache disorder and is characterized by recurrent throbbing head pain and symptoms of photophobia, phonophobia, nausea, and vomiting. Rimegepant 75 mg, an oral lyophilisate calcitonin gene-related peptide antagonist, is the first treatment approved for both the acute and preventative treatment of migraine, and the first acute therapy approved in over 20-years. The objective was to assess the cost-utility of rimegepant compared with best supportive care (BSC) in the UK, for the acute treatment of migraine in the adults with inadequate symptom relief after taking at least 2 triptans, or for whom triptans are contraindicated or not tolerated. MATERIALS AND METHODS: A de novo model was developed to estimate incremental costs and quality-adjusted life years (QALYs), structured as a decision tree followed by Markov model. Patients received rimegepant or BSC for a migraine attack and were assessed for response (pain relief at 2-h). Responders and non-responders followed different pain trajectories over 48-h cycles. Non-responders discontinued treatment while responders continued treatment for subsequent attacks, with a proportion discontinuing over time. Data sources included a post-hoc pooled analysis of the phase 3 acute rimegepant trials (NCT03235479, NCT03237845, NCT03461757), and a long-term safety study (NCT03266588). The analysis was conducted from the perspective of the UK National Health Service and Personal Social Services over a 20-year time horizon. RESULTS: Rimegepant resulted in an incremental cost-utility ratio (ICUR) of £10,309 per QALY gained vs BSC, which is cost-effectiveness at a willingness to pay threshold of £30,000/QALY. Rimegepant generated +0.44 incremental QALYs and higher incremental lifetime costs (£4,492). Improved QALYs for rimegepant were a result of less time spent with severe and moderate headache pain. CONCLUSION: This study highlights the economic value of rimegepant which was found to be cost-effective for the acute treatment of migraine in adults unsuitable for triptans.

Preventing heart disease by controlling hypertension: impact of hypertensive subtype, stage, age, and sex.

BACKGROUND: Hypertension is related to significant morbidity and mortality rates from coronary heart disease (CHD). This report examines the relative and absolute impact on risk for CHD by controlling hypertension to high normal and optimal levels. METHODS: Among all subjects with untreated or inadequately treated hypertension in the National Health and Nutrition Examination Survey (NHANES) III who were 30 to 74 years of age and without prior CHD, the 10-year risk of CHD was calculated. With the use of sampling weights, the number of CHD events by age group, hypertension subtype (isolated diastolic hypertension [IDH], systolic-diastolic hypertension [SDH], and isolated systolic hypertension [ISH]), and stage of hypertension was estimated. Risk was recalculated and the number of events reestimated, assuming a reduction in blood pressure (BP) to high normal and optimal levels. The number and proportion (population-attributable risk, or PAR%) of events that could be prevented were determined from the differences in events and risk between uncontrolled and controlled BP levels. Derived from this was the number of persons needing treatment per CHD event prevented. RESULTS: Control of hypertension to high normal levels could prevent approximately one fifth (PAR = 19%) of CHD events in men and one third (PAR = 31%) of CHD events in women, whereas control to optimal levels may prevent 37% and 56% of CHD events, respectively (P <.01 for differences between men and women). Of CHD events that could be prevented, the greatest proportion occurred from controlling BP among older persons, men, and those with stage 1 hypertension (vs stages 2 and 3) or with ISH (vs IDH or SDH). The number of persons with hypertension needing treatment to prevent one CHD event ranged from 20.5 in men to 38.6 in women when controlled to high normal BP and 10.7 in men and 21.3 in women when controlled to optimal BP. CONCLUSIONS: The greatest impact from control of hypertension occurs in older persons, men, and those with ISH, whereas the greatest PAR% occurred in women. Optimal control of BP could prevent more than one third of CHD events in men and more than half of events in women. Greater efforts to control hypertension in these populations may have a substantial impact in preventing CHD events.

Preventing coronary events by optimal control of blood pressure and lipids in patients with the metabolic syndrome.

We estimated the coronary heart disease (CHD) events that are preventable by treatment of lipids and blood pressure in patients with metabolic syndrome (MetS), a contributor to coronary heart disease (CHD). Among patients aged 30 to 74 years (without diabetes or CHD) in the United States, MetS was defined by National Cholesterol Education Program criteria. CHD events over a period of 10 years were estimated by Framingham algorithms. Events that could be prevented by statistically "controlling" blood pressure, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol to either normal or optimal levels according to national guidelines were calculated. Of 7.5 million men and 9.0 million women aged 30 to 74 years with MetS, approximately 1.5 million men and 0.45 million women, if untreated, developed CHD events in 10 years. In men and women, blood pressure control to normal levels "prevented" 28.1% and 12.5% of CHD events, respectively (p <0.01); control to optimal levels resulted in preventing 28.2% and 45.2% of events, respectively (p <0.01). Control of HDL cholesterol to normal levels resulted in preventing 25.3% of events in men and 27.3% in women; optimal control prevented 51.2% and 50.6% of events, respectively. Control of LDL cholesterol to normal levels prevented 9.3% of events in men and 9.8% of events in women; control to optimal levels prevented 46.2% and 38.1% of events (p <0.05), respectively. Control of all 3 risk factors to normal levels resulted in preventing 51.3% of events for men and 42.6% for women; control to optimal levels resulted in preventing 80.5% and 82.1% of events, respectively. Thus, many CHD events in patients with MetS may be preventable by nominal or optimal control of lipids and/or blood pressure.