2023 can be challenging for the pharmaceutical sector as it will mark the rollout of certain important drug pricing reforms across the US which were put in motion by the last year’s inflation reduction act passage. Not to be settled by the rare defeat it suffered, the sector’s pivotal lobbying group has decided to push back and set up potential elements for how the implementation of the law should happen.
It is expected that regulatory clouds will form over the M&A activity, which has picked up recently as bigger companies look forward to plugging revenue holes because of anticipated patent expiration dates that will begin happening later this decade. There could also be some scrutiny over the accelerated approvals by the FDA, which will help tighten regulatory issues.
Below are the five questions that the pharma industry is poised to face in 2023:
What are the expectations from the IRA?
When President Joe Biden inked the IRA into law last year, it rolled out a drug pricing reform that included the centrepiece provision directing Medicare to negotiate on the prices of the top-selling drugs that do not have any competition.
The law’s first provisions came into effect this month, as the monthly out-of-pocket costs of insulin now happen to be capped at $35, while the price increase of drugmakers in Medicare will be in sync with the inflation rate, over which the companies will have to pay a rebate.
The ideal process of how the prices of the drugs are going to be negotiated is a cause of concern for the industry and is currently being worked on. The Centers for Medicare and Medicaid Services, which will put in place the provisions of the law, have already begun to talk with the companies, and there is anticipation that a report will be published through regulatory rulemaking. There is an expectation that the sector is going to challenge some of them in court.
Medicare price negotiations are subject to 60 drugs throughout 2029, beginning with 10 drugs that will be selected as far as negotiations are concerned by September 1 of this year. The talks pertaining to the same are expected to be there for around a year with the first set of prices that are negotiated taking effect from 2026. The law asks the CMS to concentrate on single-source drugs.
Drugmakers such as Eli Lilly and AbbVie have already warned that their drugs might get selected for the price negotiation.
The reviewing speed up is still under microscope
There is going to be a tightening of the accelerated approvals, which were mostly common for cancer and rare disease drugs. The step is taken post the congress passed and President Biden inked the law. The FDA will thus have more control on the program post years of controversy which has been taking place on accelerated approvals with drugs placed on the market even after the failing of confirmatory trials.
The new law puts in place that FDA can require the confirmatory trials to start right before giving an accelerated approval and also helps in expediting withdrawals of products which are not proven to work. The FDA will also be given the task of developing an internal council for greater consistency when it comes to managing pathways across offices.
That said, there are still a lot of decisions that the FDA needs to make on applications that have been approved as per the previous framework. A big revelation will be on whether to pull Makena, the pre-term birth drug. The owner of this drug, Covis Pharma, has fought to ensure that it is on the market despite the confirmatory results from the trial suggesting that it is not capable of preventing complications arising from pre-term birth. Apparently, an advisory panel had already recommended its retrieval from the market and the decision pertaining to the drug whichever way it goes will give a picture to the drugmakers.
A very big US test for biosimilars
Humira from Abbvie dethroned Lipitor as the highest selling drug but from January 31, Amgen starts selling its competitor Amjevita across the US which will thereby end a 2 decade monopoly during which Humaira sales hit $20bn every year. By July, as many as eight more drugs shall enter this segment thereby making it the most competitive of all the biosimilar market since the time FDA authorised the first biologic copy almost eight years back.
At that point in time the number of Humira clones shall transform the market towards a pricing war as every manufacturer will eye to get hold of the Humira chunk, as per the analysts at Baird.
The fact is that Humira biosimilars can go on to teach insurers, drug manufacturers, and policymakers a lot about how the market can be reshaped by lower-cost treatments. For the investors of AbbVie, the graph of Humira’s 2023 sales shall aid in building their views of the company as they get to assess its future.