NCRx Pipeline Report 10.1.19

Erica Guetzlaff  •   October 1, 2019

National CooperativeRx constantly monitors the pharmaceutical pipeline. As treatment options change, it’s important to know which drugs bring the highest value. Our quarterly NCRx Pipeline Reports provide insight from our clinical team on what changes you can expect to see on the market and how they impact plan performance.

Cequa® (cyclosporine): Cequa® is a new single-use vial treatment dosed twice daily for dry eyes. It contains the same ingredient as Restasis but is a higher concentration and uses nanomicellar technology to increase absorption into corneal cells. Cequa® will join Restasis® and Xiidra® in the drug category just in time for Restasis®’ patent expiration. 16 million Americans are affected by dry eye disease, and the prevalence is higher in women than in men.1

Anticipated Launch: Quarter four of 2019.

Price: Around $500.

Impact: It would be more common for people to switch to Cequa® from Restasis® or Xiidra® rather than become a new user entirely. It is currently unclear how CVS will handle this product.

Viaskin Peanut®: This is the first epicutaneous immunotherapy (EPIT) to reduce the risk of a reaction resulting from accidental peanut exposure in those who are allergic. The drug, delivered via a patch applied to the skin, was studied in children 4-11 years of age with history of allergic reaction to tiny amounts of peanut protein (<1 peanut). 35.3 percent of study participants responded to treatment compared to 13.6 percent in the placebo group.  However, even though there was a significant difference between groups’ response rates (p<0.001), the outcome did not meet the statistical confidence interval. Additionally, the rate of side effects requiring treatment was 95.4 percent in the treatment group and 89 percent in the placebo group. Effects were mainly itching and irritation at the patch application site but did include four anaphylactic episodes in the peanut group.2 Epinephrine injections were required in 9.2 percent of the peanut group and 3.4 percent of the placebo group.

Anticipated Launch: The first US Food and Drug Administration (FDA) application was withdrawn by the manufacturer in December 2018 due to FDA concern over manufacturing and quality control. The application was resubmitted in August 2019.

Impact: There are no studies showing improvement in quality of life measures, which seems to be the main role of these therapies.  It has not been shown to produce full tolerance to peanuts and must be taken long-term to maintain effect.  Still, the potential for any degree of social, emotional or physical relief for the 1-2% of children (and their caregivers) in the United States with a peanut allergy may be enough to create demand.

Price: It is expected to cost $6,500 per year. According to The Institute for Clinical and Economic Review (ICER), in order to achieve $100,000 per quality-adjusted life year (QALY), Viaskin Peanut would need to be priced at $4,808 per year.4

Palforzia®: Palforzia® is an oral immunotherapy for reducing risk of a reaction resulting from accidental exposure to peanuts in those who are allergic. The drug is delivered in a powder form mixed into foods, with scheduled dose increases every two weeks for approximately six months until a maintenance dose is reached. Palforzia® was studied in children 4-17 years of age and included patients who were more sensitive, on average, to peanuts versus those in the Viaskin Peanut® study. 67.2 percent of patients responded to treatment versus four percent in the placebo group (p<0.001). Balancing this robust response, however, is a 52 percent incidence of abdominal pain, vomiting and nausea in the treatment group. In addition, 14 percent required use of epinephrine injections at some point, versus 6.5 percent of the placebo group.3

Anticipated Launch: Quarter three or four of 2019. An FDA advisory panel recommended Palforzia® for approval in September.

Impact: There have been no studies showing improvement in quality of life measures, which seems to be the main role of these therapies. Palforzia® has not been shown to produce full tolerance to peanuts and both products must be taken long-term to maintain effect. Still, the potential for any degree of social, emotional or physical relief for the 1-2 percent of children (and their caregivers) in the US with a peanut allergy may be enough to create demand.

Price: It is expected to cost between $31,800-$62,400 in the first year of treatment, then $3,600-$4,800 per year thereafter. According to ICER, in order to achieve $100,000 per QALY, Palforzia® would need a price tag of $3,010 per year.4

Wakix® (pitolisant): Wakix® is a histamine receptor inverse agonist which works to increase histamine, thereby promoting wakefulness. It is approved for excessive daytime sleepiness associated with narcolepsy. It was also studied in patients with cataplexy (sudden muscle weakness affecting some with narcolepsy), but the FDA requested additional data before it will consider the cataplexy indication. In clinical trials, those taking Wakix® saw an improvement from severe daytime sleepiness to mild-moderate daytime sleepiness (per the Epworth Sleepiness Scale) within the eight-week study duration.5 While another therapeutic option in the narcolepsy treatment arsenal is exciting, it does not come without baggage. It comes with risk of serious heart arrhythmias in susceptible people and many drug interactions, including antihistamines, birth control and some common antidepressants.

Anticipated Launch: Quarter four of 2019.

Impact: Utilization of Wakix® will likely replace utilization for other products like modafinil and Sunosi (and maybe some Xyrem). There is potential for much higher impact if Wakix® can obtain the indication for cataplexy.

Price: Currently unknown. The 2017 price in the United Kingdom is £310 for 30 tablets (about $382 in US dollars).7 It will most likely be priced much higher in the United States, of course.

Lasmiditan: Lasmiditan is a serotonin agonist–like “triptan” drugs–but doesn’t cause narrowing of blood vessels like “triptans” do. This is crucial because many patients with migraines also have cardiovascular risk factors (> age 40, uncontrolled high blood pressure, diabetes, smoking, high cholesterol) which make vasoconstriction more dangerous. Treatment options are very limited for this group of patients, with some even resorting to opioid use. Lasmiditan was studied in patients with and without cardiovascular risk factors and was found to relieve headache pain completely within two hours in about 35 percent of patients, regardless of cardiovascular history.8 In terms of cardiovascular safety, lasmiditan appears to cause a more rapid heart rate than the placebo. Additionally, some raw data related to adverse effects seems to indicate a nonsignificant higher incidence of other cardiovascular adverse effects for lasmiditan over placebo, such as fainting and shortness of breath. While preliminary data seems reassuring, some questions remain regarding the actual risk of cardiovascular adverse events related to lasmiditan use.

Anticipated Launch: Quarter four of 2019. Lilly, the manufacturer, has not announced the anticipated FDA approval date.

Impact: Any new option in the migraine category can potentially impact utilization significantly, as there is a subset of patients who fail to benefit from current treatments.

Price: Currently unknown. It is likely to be comparable to other migraine rescue treatments, such as triptans.

 

  1. Farrand KF, Fridman M, Stillman IÖ, Schaumberg DA. Prevalence of diagnosed dry eye disease in the united states among adults aged 18 years and older. Am J Ophthalmol 2017 Oct;182:90-98.
  2. Fleischer DM, Greenhawt M, Sussman G, et al. Effect of epicutaneous immunotherapy vs placebo on reaction to peanut protein ingestion among children with peanut allergy: the PEPITES randomized clinical trial. JAMA 2019; 321(10):946-955.
  3. Vickery BP, Vereda A, Casale TB. AR101 Oral immunotherapy for peanut allergy.  N Engl J Med 2018; 379:1991-2001.
  4. Tice JA, Herron-Smith S, Tsiao E, et al. Oral Immunotherapy and Viaskin® Peanut for Peanut Allergy.  Institute for clinical and economic reviewhttps://icer-review.org/wp-content/uploads/2018/10/ICER_PeanutAllergy_Evidence_Report_052819.pdf  Published May 2019. Accessed September 4, 2019
  5. Wakix [package insert]. Plymouth Meeting, PA:  Harmony Biosciences; 2019.
  6. Lehert P, Falissard B. Multiple treatment comparison in narcolepsy: a network meta-analysis.  Sleep 2018; 41(12).
  7. Midlands and Lancashire Commissioning Support Unit. New medicine recommendation: pitolisant (Wakix) for the treatment of narcolepsy with or without cataplexy.  Jubilee House, Lancashire Business Park 2017: 1-13.  Accessed on September 11, 2019 at http://www.lancsmmg.nhs.uk/download/newdrug%20reviews/Pitolisant-FINAL-new-medicine-assessment-FOR-WEBSITE-price-adjusted.pdf.
  8. Shapiro RE, Hochstetler HM, Dennehy EB, et al. Lasmiditan for actue treatment of migraine in patients with cardiovascular risk factors: post-hoc analysis of pooled results from 2 randomized, double-blind, placebo-controlled, phase 3 trials.  J Headache Pain 2019; 20(1): 90.
  9. Imitrex [package insert]. Research Triangle Park, NC:  GlaxoSmithKline; 2017.