Hospitals Sue Trump to Keep Negotiated Prices Secret

December 5, 2019

The nation’s hospital groups sued the Trump administration on Wednesday over a new federal rule that would require them to disclose the discounted prices they give insurers for all sorts of procedures.

The hospitals, including the American Hospital Association, argued in a lawsuit filed in United States District Court in Washington that the new rule “is unlawful, several times over.”

The nation’s hospital groups sued the Trump administration on Wednesday over a new federal rule that would require them to disclose the discounted prices they give insurers for all sorts of procedures.

The hospitals, including the American Hospital Association, argued in a lawsuit filed in United States District Court in Washington that the new rule “is unlawful, several times over.”

They argued that the administration exceeded its legal authority in issuing the rule last month as part of its efforts to make the health care system much more transparent to patients. The lawsuit contends the requirement to disclose their private negotiations with insurers violates their First Amendment rights….

Read the full The New York Times article

Highmark Reports Positive Results on OBC with AstraZeneca

December 5, 2019

Highmark recently said its outcomes-based contract (OBC) with AstraZeneca showed positive results for its commercial members with asthma and chronic obstructive pulmonary disease (COPD) taking Symbicort — to the point where the drug manufacturer didn’t have to pay back a rebate to the insurer.

Under Highmark’s year-long agreement with AstraZeneca, announced in April 2018, more than half of its commercial members taking Symbicort (budesonide and formoterol fumarate dihydrate) who had a primary diagnosis of asthma or COPD experienced stabilized or improved symptoms, the insurer says.

By Judy Packer-Tursman

Highmark recently said its outcomes-based contract (OBC) with AstraZeneca showed positive results for its commercial members with asthma and chronic obstructive pulmonary disease (COPD) taking Symbicort — to the point where the drug manufacturer didn’t have to pay back a rebate to the insurer.

Under Highmark’s year-long agreement with AstraZeneca, announced in April 2018, more than half of its commercial members taking Symbicort (budesonide and formoterol fumarate dihydrate) who had a primary diagnosis of asthma or COPD experienced stabilized or improved symptoms, the insurer says.

Overall, Highmark’s involvement in OBCs is growing rapidly. The insurer “will have 15 [such] contracts in place by January 2020 and we’re looking to do more,” says Kayse Reitmeyer, Pharm.D., Highmark’s manager of pharmaceutical manufacturer relations and rebate administration.

She explains that Highmark “has moved on to different types of contract designs” for OBCs, including medical outcomes-based agreements, where the manufacturer offers a design centered around a drug’s clinical trial results; “persistency” or medication adherence-based agreements to track whether members are continuing therapy; and total cost-of-care contracts that track both pharmacy and medical spend.

To date, Highmark has publicly disclosed two OBCs: a total cost-of-care design on Jardiance (empagliflozin), marketed by Boehringer Ingelheim Pharmaceuticals, Inc., and Eli Lilly and Co. for patients with diabetes; and a persistency and adherence-based design on Takeda Pharmaceuticals America, Inc.’s Entyvio (vedolizumab) for patients with irritable bowel syndrome, ulcerative colitis or Crohn’s disease, Reitmeyer says. Highmark expects to disclose two to three more OBCs in the next few months “and share some Jardiance results soon,” she says.

Looking ahead, Highmark “will have a total cost-of-care contract in respiratory, tracking per member per month [PMPM] or per member per year [PMPY], looking at all medical and pharmacy costs in a certain drug class,” Reitmeyer says.

As for Symbicort, Highmark is in discussions with AstraZeneca about evolving that contract, she adds.

What Side Effects? Problems With Medicines May Be Vastly Underreported to the FDA

December 4, 2019

It’s no secret that the many side effects caused by medicines do not get reported to the Food and Drug Administration, but a new report suggests the magnitude of underreporting is far greater than imagined.

After examining side effects that were conveyed to the regulator for five widely used medicines — two different types of arthritis treatments, an antipsychotic, and a blood thinner — just 1% of an estimated 276,000 serious adverse events had been reported in 2017.

It’s no secret that the many side effects caused by medicines do not get reported to the Food and Drug Administration, but a new report suggests the magnitude of underreporting is far greater than imagined.

After examining side effects that were conveyed to the regulator for five widely used medicines — two different types of arthritis treatments, an antipsychotic, and a blood thinner — just 1% of an estimated 276,000 serious adverse events had been reported in 2017….

Read the full Stat article

Datapoint: FDA Approves Two New Sickle Cell Therapies

December 4, 2019

The FDA in recent weeks approved two new sickle cell disease therapies with potential to reshape the market basket, Global Blood Therapeutics’ Oxbryta, a once-daily pill, and Novartis’ Adakveo, a monthly infusion. In the pharmacy benefit, the most advantaged therapy for the treatment of sickle cell disease is currently Bristol-Meyers Squibb’s Droxia, which holds preferred formulary status for 44% of covered lives.

The FDA in recent weeks approved two new sickle cell disease therapies with potential to reshape the market basket, Global Blood Therapeutics’ Oxbryta, a once-daily pill, and Novartis’ Adakveo, a monthly infusion. In the pharmacy benefit, the most advantaged therapy for the treatment of sickle cell disease is currently Bristol-Meyers Squibb’s Droxia, which holds preferred formulary status for 44% of covered lives.

SOURCE: MMIT Analytics, as of 11/26/19

New Acute Migraine Medications May Not Shake Up Formularies

December 4, 2019

New oral medications for acute migraine — one pending launch and two more that could be approved in the coming months — likely won’t shake up formulary coverage for a condition that’s largely treated by generic triptan medications, pharmacy benefit experts say.

Eli Lilly and Co. on Oct. 11 received FDA approval for its drug Reyvow (lasmiditan), an oral medication that’s the first serotonin (5-HT)1F receptor agonist to be approved for migraine. Meanwhile, Allergan on Nov. 19 said it’s on track for December FDA consideration of ubrogepant, an oral CGRP receptor antagonist for acute migraine. Biohaven Pharmaceuticals also has applied for FDA approval on its oral CGRP antagonist rimegepant.

By Jane Anderson

New oral medications for acute migraine — one pending launch and two more that could be approved in the coming months — likely won’t shake up formulary coverage for a condition that’s largely treated by generic triptan medications, pharmacy benefit experts say.

Eli Lilly and Co. on Oct. 11 received FDA approval for its drug Reyvow (lasmiditan), an oral medication that’s the first serotonin (5-HT)1F receptor agonist to be approved for migraine. Meanwhile, Allergan on Nov. 19 said it’s on track for December FDA consideration of ubrogepant, an oral CGRP receptor antagonist for acute migraine. Biohaven Pharmaceuticals also has applied for FDA approval on its oral CGRP antagonist rimegepant.

Mesfin Tegenu, R.Ph., president of PerformRx, doesn’t expect widespread uptake of Reyvow. “The launch of lasmiditan will likely not change the formulary status quo when it hits the market, as it most likely will become a niche medication for patients inadequately controlled on triptans, or for those who cannot take triptans,” Tegenu tells AIS Health. “This is primarily due to warnings on the label for driving impairment and central nervous system depression.”

PBMs could have the chance to consider how to handle Reyvow and ubrogepant soon, although it’s not clear how soon. Eli Lilly hasn’t yet set a launch date for Reyvow, while Allergan said it expects ubrogepant to be the first approved oral CGRP receptor antagonist for the acute treatment of migraine.

“As with any new product, [ubrogepant] will need to be analyzed as part of the class of drugs for this indication,” Tegenu says. “Since this is the first oral version of a CGRP antagonist, it does have some administration advantages over injectable products.”

Payers can implement utilization management programs that direct use of these new drugs to those who have failed or cannot tolerate triptans, says Nicole Kjesbo, principal clinical program pharmacist with Prime Therapeutics LLC. “Additionally, payers will consider exclusion strategies and potentially value-based contracts as a means to manage cost and appropriate therapy,” she says.