In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing


In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing
Pharmacist Clint Hopkins holds bottles of the HIV prevention drugs Descovy (L) and Truvada, Oct. 7, 2019, in Sacramento, CA (Rich Pedroncelli, AP Images)

The fed­er­al gov­ern­ment is­sued guid­ance Mon­day stat­ing that al­most all health in­sur­ers must cov­er HIV pre­ven­tion drugs — such as Gilead’s Tru­va­da and De­scovy — with no cost-shar­ing, as well as as­so­ci­at­ed lab test­ing and fol­low-up vis­its.

In­sur­ers were al­ready re­quired to quit charg­ing out-of-pock­et fees for the drugs, called HIV Pre­ex­po­sure Pro­phy­lax­is (PrEP), by Jan­u­ary of this year. But now in­sur­ers have 60 days to com­ply with the ad­di­tion­al re­quire­ments, in­clud­ing no-cost ser­vices like base­line and fol­low-up test­ing, as well as mon­i­tor­ing, ac­cord­ing to the guid­ance.

The news comes about two years af­ter the US Pre­ven­tive Ser­vices Task Force grant­ed an “A” rat­ing to PrEP treat­ments, re­quir­ing clin­i­cians to of­fer “ef­fec­tive an­ti­retro­vi­ral ther­a­py to per­sons who are at high risk of hu­man im­mun­od­e­fi­cien­cy virus (HIV) ac­qui­si­tion.”

Tru­va­da was ap­proved back in 2004 to treat HIV, and was sanc­tioned by the FDA as a pre­ven­ta­tive treat­ment in 2012. Ac­cord­ing to the CDC, dai­ly PrEP re­duces the risk of get­ting HIV via sex­u­al in­ter­course by more than 90%.

AIDS ac­tivists, law­mak­ers and pa­tients have crit­i­cized Gilead over the years re­gard­ing the price of Tru­va­da, which cost near­ly $2,000 for a one-month sup­ply with­out in­sur­ance back in 2020. In May 2019, ad­vo­ca­cy or­ga­ni­za­tion Health GAP tes­ti­fied to the US House com­mit­tee on over­sight and re­form that gener­ic ver­sions in oth­er coun­tries were be­ing sold for as lit­tle as $6 per month.

“While un­der-uti­liza­tion of PrEP is caused by mul­ti­ple fac­tors, it is clear that price is a bar­ri­er that in­hibits broad ac­cess,” the group said.

Gilead spent a pri­or­i­ty re­view vouch­er to clear De­scovy for PrEP back in 2019, just be­fore Tru­va­da gener­ics were set to hit the mar­ket in 2020. Last year, Gilead’s HIV prod­ucts raked in $16.9 bil­lion, up 3% from 2019. Te­va launched the first gener­ic ver­sion of Tru­va­da in Oc­to­ber, charg­ing $48.51 per tablet.

In No­vem­ber 2020, the HIV+He­pati­tis Pol­i­cy In­sti­tute re­port­ed that come 2021, “many plans” would not be in com­pli­ance with the le­gal re­quire­ment to of­fer PrEP treat­ment with­out cost-shar­ing, and urged in­sur­ers to take cor­rec­tive ac­tion.

“The HIV com­mu­ni­ty and pub­lic health lead­ers have been work­ing for years to get to the day when in­sured peo­ple who are at risk of HIV can ac­cess PrEP with­out cost-shar­ing,” ex­ec­u­tive di­rec­tor Carl Schmid said at the time. “Un­for­tu­nate­ly, it ap­pears that some in­sur­ers and in­sur­ance reg­u­la­tors do not share our en­thu­si­asm. I hope that will be cor­rect­ed im­me­di­ate­ly.”

While PrEP will soon be read­i­ly avail­able for in­sured pa­tients, unin­sured pa­tients could still be left with no pro­tec­tion. Ac­cord­ing to an NBC News re­port, Gilead pro­vides PrEP for free to low­er-in­come peo­ple who aren’t in­sured, but it doesn’t cov­er as­so­ci­at­ed ser­vices. And, safe­ty net clin­ics are set to lose $100 mil­lion in an­nu­al HIV pre­ven­tion funds due to a re­cent de­ci­sion by Gilead.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing
Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing

Unlock this story instantly and join 112,400+ biopharma pros reading Endpoints daily — and it's free.

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing

Unlock this article along with other benefits by subscribing to one of our paid plans.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing
Severin Schwan (AP Images)

Four years after Roche opted to resurrect its late-stage effort on their Alzheimer’s program for gantenerumab following a clear failure, Roche CEO Severin Schwan is signaling some fresh enthusiasm for its blockbuster prospects in the wake of the controversial Aduhelm OK.

Schwan told reporters that company execs are engaged in ongoing talks with the FDA as speculation continues to percolate around its chances based on biomarker data alone, now that regulators have established a precedent using an accelerated approval pathway process with no convincing evidence of efficacy in helping patients retain their cognitive skills. In Aduhelm’s case, the drug reduced the amount of amyloid in the brain and Biogen was able to win the accelerated approval on what the FDA called a reasonable expectation of success.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing

Unlock this story instantly and join 112,400+ biopharma pros reading Endpoints daily — and it's free.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing

Late in the Covid-19 pandemic, a spotlight has been cast on Africa as the continent has lagged behind on vaccine rollouts. Now, looking to make a difference, the US will drop a major investment in South African manufacturer Aspen Pharmaceutical to keep up with demand.

The US government will dole out $200 million to Aspen’s Gqeberha plant to expand J&J vaccine production, News24 in South Africa has reported. US Consul-General Will Stevens announced the investment in an email to Eastern Cape government and Eastern Cape Premier Oscar Mabuyane confirmed it in a press briefing, News24 reports.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing

Unlock this story instantly and join 112,400+ biopharma pros reading Endpoints daily — and it's free.

India is getting a manufacturing boost that will add the capacity to produce another 1 billion injectables.

Recipharm announced the construction of a new fill-finish facility in Uttarakhand, near Dehradun, in collaboration with the Sobti family. The development is the latest move in a partnership with the family, which began in 2019 after Recipharm invested in Nichepharm.

The site will up Recipharm’s sterile fill-finish service to complement already existing locations in France, Germany and Italy. The project’s next step is to gain authorization from European regulators.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing

Moderna, Takeda and the Japanese government have teamed up to distribute 50 million doses of Moderna’s vaccine — including a booster shot if it’s authorized — in 2022. That doubles the total vaccines signed on from 2021, bringing the number to 100 million doses for Japan.

Moderna is responsible for the manufacturing and supply of the jab, while Takeda is responsible for the import, regulatory, development and distribution activities.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing
John Houston, Arvinas CEO

As one of the largest multinational corporations in the world, Pfizer has its tendrils in everything. The Big Pharma has potentially hundreds of billions of dollars to play with, and when it decides to go big, it can go as big as it wants.

And did Pfizer ever on Thursday.

Returning to one of its partners in protein degradation, Pfizer is teaming up again with Arvinas to advance and vastly expand a program for breast cancer. As part of the deal, Pfizer is handing over $1 billion immediately — $650 million in upfront cash and $350 million in an equity investment — and promising up to another $1.4 billion in regulatory and commercial milestones.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing

Unlock this story instantly and join 112,400+ biopharma pros reading Endpoints daily — and it's free.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing
Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

As Biogen execs bemoaned the negative media coverage around Aduhelm’s approval a month ago, the biotech isn’t gaining much traction yet in using its new drug, largely due to a lack of insurance coverage, according to an earnings call Thursday.

Management indicated that of the nearly 900 sites that were prepped and ready following Aduhelm’s approval, 325 of those, or about 35%, have completed a positive pharmacy and therapeutics (P&T) review or won’t require one. The review is a step some hospitals or health systems take prior to using a new drug. Some major sites, however, have said they won’t participate.

In 60 days, most insurers will be required to cover HIV prevention drugs and related services with no cost-sharing

Albireo scored a big breakthrough when it won approval by the FDA and EMA this week for Bylvay (odevixibat), the first drug approved to treat pruritus in patients suffering from all forms of progressive familial intrahepatic cholestasis. And they wasted no time in rolling out a jaw-dropping price. In a call with analysts on Wednesday, company execs outlined a weight-based approach they say will create an average per-patient price of $385,000.