The Institute for Clinical and Economic Review (ICER) issued a final evidence report assessing the comparative clinical effectiveness and economic value of three acute treatments for migraine – lasmiditan (Reyvow, Eli Lilly and Co.), rimegepant (Biohaven Pharmaceutical Holding Co. Ltd.) and ubrogepant (Ubrelvy, Allergan plc) – following a review at the January 2020 public meeting of the Midwest Comparative Effectiveness Public Advisory Council (CEPAC), one of ICER’s three independent evidence appraisal committees. Although Midwest CEPAC panelists deemed the evidence adequate to show a net health benefit with the three therapies compared with no treatment, they found the evidence insufficient to show superior net benefit for any of the treatments compared to triptans. All panelists found the evidence insufficient to distinguish the net benefit between rimegepant and ubrogepant, and a majority found the evidence insufficient to distinguish between either of those two or lasmiditan. Given that evidence of response to the newer agents did not suggest their superiority to triptans, a key policy recommendation was to require patients to try triptans before receiving coverage for the newer agents, if clinically eligible. ICER health-benefit price benchmarks suggested a price range of $2,800 to $3,200 per year for lasmiditan, lower than the treatment’s annual list price of $4,610, and between $4,200 and $4,600 per year for rimegepant and ubrogepant, slightly lower than the $4,896 annual list price for ubrogepant. Rimegepant’s list price is unknown as it is not yet approved by the FDA. Because the treatments do not appear to lengthen patients’ lives, ICER did not calculate the price needed to reach alternative thresholds based on equal value of life years gained. For new agents, ICER noted there is no evidence-based reason to limit coverage based on a metric of severity, such as number of migraines per month.

A split U.S. Court of Appeals for the Federal Circuit denied a request for an en banc rehearing of Horizon Pharma USA Inc. v. Actavis Laboratories UT Inc. The denial leaves standing the Federal Circuit’s October 2019 split decision affirming a lower court’s ruling that several claims in method-of-use patents protecting Horizon’s osteoarthritis drug, Pennsaid 2% (diclofenac sodium topical solution), were indefinite and that Actavis did not induce infringement of a method patent with its labeling instructions. In her partial dissent in the October decision, Judge Pauline Newman took issue with the majority’s finding of indefiniteness, which it based on the use of the clause “consisting essentially of” in some of the claims. She argued that the distinction the majority made between “consisting of” and “consisting essentially of” was contrary to precedent and would cast “countless patents into uncertainty.” The majority in the October opinion tried to limit the impact of the decision to the particular facts of the case. In the Feb. 25 denial of an en banc, Newman once again dissented, along with three other judges. The new dissent, written by Judge Alan Lourie, said an en banc rehearing was needed “to clarify that the ‘consisting essentially of’ language does not render these and similar claims that do not recite advantages of an invention or methods of measuring them indefinite.”

The FDA placed products from a crude heparin supplier on import alert in January 2020 and then slapped it with a warning letter this month. The letter to Yibin Lihao Bio-technical Co. Ltd., of Yibin, China, noted that during a pre-inspectional call in July 2019, company officials informed the FDA that the firm had not manufactured any materials for months. They repeated that claim when the investigator showed up, adding that they were only testing equipment. During a walkthrough of the warehouse, the investigator saw an employee leaving with a fiber drum. The investigator inquired about the contents of the drum and was told that it contained a redacted kind of bags. “However, inspection of the drum revealed two batches of crude heparin manufactured just a few days before the FDA inspection,” according to the letter, and the company had no records for the batches. In its response to the inspection report, the company blamed the lack of records on deficiencies in its recordkeeping practices. It also told the FDA that it was training its warehouse employees and said it would not sell to European or U.S. markets before official approval. The FDA wasn’t satisfied with that response, saying Yibin Lihao didn’t adequately address how it would remediate its documentation practices or assess the impact of those practices on distributed drugs. The warning letter also noted that during the walkthrough, the FDA investigator saw numerous records, including batch production records for heparin, on the floor, desks and cabinets of the company’s quality assurance office. An employee told the investigator that the records were generated to support an application for government funding, but the crude heparin batches specified in the records actually hadn’t been manufactured. However, later in the inspection, the company said all the records in the office were associated with genuine crude heparin batches.

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