NCRx Pipeline Report 7.1.20
National CooperativeRx constantly monitors the pharmaceutical pipeline. As treatment options change, it’s important to know how those changes could impact your plan and which drugs bring the highest value. Our quarterly NCRx Pipeline Reports highlight some of the newest therapies coming to market and are not intended to imply formulary placement or coverage by CVS Caremark.
Winlevi® (clascoterone): Winlevi® is a first-in-class topical androgen receptor inhibitor, a 1% cream, expected to be approved in August 2020 for treatment of acne. A topical solution is also in phase II trials for androgenic alopecia, also known as “male pattern baldness.” Androgen receptors are found in the skin and interact with testosterone to cause acne. Drugs that block this process are effective for acne, but the existing products on the market (spironolactone and certain oral contraceptives) are only available orally and come with more side effects than topical products typically do. In phase III clinical trials, robust treatment success occurred in about 20% of patients using clascoterone 1% cream, versus 7-9% of those using a placebo.1 Side effects were very mild and uncommon. For perspective, spironolactone has been shown to produce improvements in about 85% of female patients.2
Anticipated Launch: September of 2020.
Impact: Small overall, as it’s not likely to be used as a first-line treatment. The impact would be larger for males, as they are unable to use existing systemic anti-androgenic drugs (spironolactone and oral contraceptives).
Price: Currently unknown, yet the manufacturer has stated a high price is not planned.
Filgotinib: Filgotinib will join Xeljaz®, Olumiant® and Rinvoq® as another oral janus kinase (JAK) inhibitor for rheumatoid arthritis (RA). Of these agents, Rinvoq® and Xeljanz® are preferred drugs on the CVS Advanced Control Specialty Formulary. In a placebo-controlled trial, 66% of patients taking filgotinib 200mg saw a 20% improvement in their condition, compared to 31% of those in the placebo group.3 Among patients who had failed three or more disease-modifying drugs (DMARDs) previously, 70% experienced a 20% improvement versus 53% of those in the placebo group. Filgotinib was mostly well-tolerated; notable side effects were upper respiratory infections, shingles infections and headaches. JAK inhibitors are generally intended for patients who have failed methotrexate and possibly anti-tumor necrosis factor drugs like Humira.® Filgotinib is also being studied for numerous other autoinflammatory conditions.
Anticipated Launch: September of 2020.
Impact: Low. It’s likely to replace other therapies for RA and the impact could be higher when approvals for additional indications occur.
Price: Currently unknown, but likely to be on par with other JAK inhibitors on the market at about $5,000 per month.
Risdiplam: Risdiplam will be the first oral drug, a liquid, for spinal muscular atrophy (SMA) types I,II and III, diseases that result in devastating loss of motor function and sometimes death. The drug works by “turning on” the survival motor neuron-2 (SMN2) gene so it can make SMN protein. It met primary endpoints in two clinical trials to date, but the data from the FIREFISH trial in type I patients is the most interesting as those patients have more severe and treatment-refractory disease. In the FIREFISH trial, 29% of infants were able to sit unsupported for five seconds and 44% of them were able to hold their head upright by month 12.4 Without treatment, type I SMA patients do not achieve these milestones and have a life expectancy of less than two years. The SUNFISH trial demonstrated improvements in motor function of patients with SMA type II and III, ages 2-25 years, with the most benefit seen in patients between two and five years.5 Two additional trials are underway to study the drug in patients who have failed other SMA treatments and in newborn patients who are not yet symptomatic. It’s likely that Zolgensma will continue to be the treatment of choice for SMA type I patients, even after the introduction of risdiplam, because it can be given before symptoms present. Risdiplam offers a convenient and effective treatment option, however, for type I patients who cannot use Zolgensma or for type II and III patients.
Anticipated Launch: September of 2020.
Impact: High. While SMA is a rare disease, this represents the first oral treatment option. Other treatments include Spinraza, which is approved for all types of SMA and administered intrathecally (into the spinal fluid) and Zolgensma which is for SMA type I and administered intravenously.
Price: Currently unknown. Risdiplam’s manufacturer, Roche, has stated they intend to undercut Spinraza and Zolgensma to help win payers and patients. Spinraza is priced at $750,000 for the first year and $375,000 annually thereafter, and Zolgensma costs $2.1 million for a one-time treatment.
Trelegy® (fluticasone furoate/umeclidinium/vilanterol): If approved, this will be the first combination triple therapy inhaler for asthma, essentially combining the drugs in Breo Ellipta® and Incruse Ellipta® into one inhaler. Trelegy® has been approved for chronic obstructive pulmonary disease (COPD) since 2017. The cornerstone of asthma treatment is inhaled corticosteroids, such as fluticasone furoate found in Trelegy.® Generally, long-acting beta agonists (LABA), such as vilanterol, are added if symptoms cannot be controlled. If asthma cannot be controlled on these two agents, adding a long-acting muscarinic antagonist (LAMA), such as umeclidinium, is an option. In the CAPTAIN trial, Incruse Ellipta® demonstrated a statistically significant improvement in lung function measured by FEV1 when added to Breo Ellipta®, compared with Breo Ellipta® alone.6 There was a numerical reduction in asthma exacerbations (periods of worsened symptoms) as well, but it did not reach statistical significance. Given the potential need for multiple drugs to achieve symptom control, combination inhalers can provide some convenience and improve adherence. Currently, Trelegy® is the only steroid/LABA/LAMA available and is offered at a lower price than Breo® and Incruse® combined. It’s a preferred product on the CVS Standard and Advanced Control Formularies.
Anticipated Approval: August of 2020.
Impact: Low to moderate. 18% of patients on a steroid + LABA with good adherence have poor control of asthma symptoms. While these patients already have access to a LAMA today, the added convenience of a combination triple therapy inhaler could improve adherence to therapy and ultimately, fewer costly exacerbations.
Price: Trelegy® is priced at $573, compared to $362 for Breo Ellipta® + $344 for Incruse Ellipta® ($706 total).
- Hebert A; Thiboutot D, Gold LS, et al. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne. JAMA Dermatol April 22, 2020 online.
- Yemisci A, Gorgulu A, Piskin S. Effects and Side-Effects of Spironolactone Therapy in Women With Acne. J Eur Acad Dermatol Venereol Mar 2005; 19(2): 163-6.
- Genovese MC, Kalunian K, Gottenberg JE, et al. Effect of filgotinib vs placebo on clinical response in patients with moderate to severe rheumatoid arthritis refractory to disease-modifying antirheumatic drug therapy: the FINCH 2 randomized clinical trial. JAMA 2019 Jul 23; 322(4): 315-325.
- Roche’s risdiplam shows significant improvement in survival and motor milestones in infants with Type 1 spinal muscular atrophy (SMA); 2020. Available at: https://www.roche.com/media/releases/med-cor-2020-04-28.htm. Accessed June 4, 2020
- Roche’s risdiplam showed significant improvement in motor function in people aged 2-25 with type 2 or 3 spinal muscular atrophy; 2020. Available at https://www.roche.com/media/releases/med-cor-2020-02-06.htm. Accessed June 4, 2020
- Phase III CAPTAIN study of Trelegy Ellipta in patients with asthma meets primary endpoint; 2019. Available at https://www.gsk.com/en-gb/media/press-releases/phase-iii-captain-study-of-trelegy-ellipta-in-patients-with-asthma-meets-primary-endpoint/. Accessed June 9, 2020.
- Davis J, Trudo F, Siddall J, Small M. Burden of asthma among patients adherent to ICS/LABA: A real-world study. J Asthma 2019 Mar;56(3):332-340.