Just as a new respiratory mechanism of action is making strides through biopharma’s pipeline, the price of recently launched biological asthma agents is being called into question. The US health economics body Icer says in a draft report that Glaxosmithkline's Nucala, Astrazeneca's Fasenra and Teva's Cinqair all fail cost-effectiveness standards.
This might be seen as a negative for Anaptysbio, which just reported phase II data in asthma with its IL-33-targeting agent etokimab, as well as respiratory rivals looking at this and other new mechanisms. Even if these projects make it to market, looming pricing pressure and increasing competition ought to raise commercial questions. There is room for improvement in asthma treatment, but it is a serious question whether there is room for several blockbusters, and whether the R&D investment can be justified.
First the good news. Anaptysbio reported positive phase II results for its anti-IL-33 antibody etokimab, previously known as ANB020, prompting a 10% share rise on Monday and enabling a $200m share offering. Etokimab is the first of five clinical-stage assets in this class to yield phase II data in asthma.
The 25-patient trial found that severe asthma patients with elevated blood eosinophils who received an etokimab infusion saw a 15% improvement in forced expiratory volume (FEV), compared with 4% for patients on placebo. The improvement in lung function was accompanied by a 40% reduction in blood eosinophils, a sign that the antibody was having its desired biological effect.
Stifel analyst Derek Archila reckoned that the FEV improvement of 15% was in line with investor expectations. But he added that many might want to see data from a larger phase IIb study with endpoints typically used in a pivotal trial – such as reducing asthma exacerbations and hospitalisations – before raising their expectations. EvaluatePharma’s consensus of sellside analysts forecasts etokimab asthma sales of $88m in 2024, while also penciling in $382m for atopic dermatitis and $241m for anaphylaxis.
Etokimab is the only IL-33 to earn a forecast in asthma.
|Anti-IL 33 antibodies in clinical development|
|Status||Product||Company||2024e asthma sales ($m)|
|Phase II||ANB020 (etokimab)||Anaptysbio||88|
|Phase I||IL-33 Antibody||Eli Lilly||-|
Paying the bills
Assuming IL-33s succeed in the clinic and with regulators, the question for biopharma groups is whether they can expect a novel asthma drug to generate the blockbuster sales of Advair and Symbicort, for example. The emergence of numerous biological agents for more severe patients means a vigorous fight over a small population, giving payers enhanced leverage.
This could be aggravated by the Institute for Clinical and Economic Review’s draft analysis of the new asthma agents Nucala, Fasenra, Cinqair, along with Sanofi/Regeneron's Dupixent – which is due an FDA decision in asthma by October 19 – and Roche and Novartis's older biological Xolair.
None of the drugs actually met the cost-effectiveness threshold of $150,000 per quality adjusted life year (QALY) at their net prices, or assumed net price for Dupixent once it is approved.
|Heavy costs for asthma biologicals|
|Product||Total lifetime costs||Cost per QALY*|
|Standard of care||$120,000|
|Source: ICER. *Compared with standard of care. **Based on the projected price.|
Icer’s influence has been growing with payers; the pharmacy-benefit manager (PBM) CVS recently said it would allow clients to exclude from its formulary any drug that costs more than $100,000 per QALY (CVS decides to make Icer an American Nice, August 16, 2018).
Whether CVS’s clients, which are typically self-insured employer-sponsored health plans, routinely start applying that standard is an open question, but the PBM is setting some clear expectations.
The respiratory space went through a shakeup three years ago when the big PBM Express Scripts excluded Glaxo's inhaled drug Advair from its formulary, and payer pressure has limited the growth of newer inhaled medications like Glaxo's follow-on product Breo Ellipta.
With so many biologicals piling in, and clear scepticism about their high prices, that scenario could easily repeat itself – something to which Anaptysbio and fellow IL-33 developers need to pay attention.