When drug val­ue as­sess­ment meets re­al-world ev­i­dence: ICER en­lists Ae­tion in pric­ing eval­u­a­tion

In a union of two of the hottest trends in the US bio­phar­ma world, ICER is team­ing up with a high-pro­file com­pa­ny to in­te­grate re­al-world ev­i­dence in their as­sess­ment of treat­ment val­ue.

The drug pric­ing watch­dog — for­mal­ly the In­sti­tute for Clin­i­cal and Eco­nom­ic Re­view — said it will uti­lize Ae­tion’s ev­i­dence plat­form in “se­lect up­com­ing as­sess­ments” and their new 24-month re-eval­u­a­tions of drugs grant­ed ac­cel­er­at­ed ap­proval by the FDA.

Even though ICER doesn’t play an of­fi­cial role in set­ting drug prices, its ver­dicts on whether treat­ments are cost-ef­fec­tive are in­creas­ing­ly shap­ing pay­er at­ti­tude and con­sumer per­cep­tion, as well as, gen­er­al dis­course as the heat­ed de­bate around US drug prices rages on.

Car­olyn Mag­ill

Led by Unit­ed­Health vet Car­olyn Mag­ill, Ae­tion de­rives much of its da­ta from in­sur­ance claims, but it al­so works with elec­tron­ic health records, reg­istries and clin­i­cal tri­als. The FDA and Brigham and Women’s Hos­pi­tal have a pact in place with the com­pa­ny to try pre­dict­ing the re­sults of ran­dom­ized clin­i­cal tri­als in a pi­lot project in­volv­ing sev­en stud­ies.

Scott Got­tlieb, who pushed the in­dus­try to try new things with RWE dur­ing his tenure as FDA com­mis­sion­er, joined Ae­tion’s board a few months af­ter leav­ing the agency.

David Whitrap

For its part, ICER has com­mit­ted to ex­pand­ing its RWE use, not on­ly us­ing ex­ist­ing sources such as man­u­fac­tur­ers and pa­tient or­ga­ni­za­tions but ex­plor­ing ways to gen­er­ate da­ta that can com­ple­ment pub­lished sources. The deal with Ae­tion al­lows them to do it at greater scale, David Whitrap, ICER’s VP of com­mu­ni­ca­tions and out­reach, told End­points News.

Where­as RWE can come in handy for com­par­isons to ex­ist­ing treat­ments and the nat­ur­al trend of cer­tain con­di­tions (such as sick­le cell dis­ease, where ICER is con­duct­ing a re­view of ther­a­pies with Ae­tion’s help), their re­la­tion­ship will be most use­ful in the new process they are pi­lot­ing: re-eval­u­at­ing treat­ments af­ter they’ve been on the mar­ket for sev­er­al years.

“Ran­dom­ized clin­i­cal tri­als re­main the gold stan­dard for de­vel­op­ing un­bi­ased ev­i­dence, but as the FDA is in­creas­ing­ly ap­prov­ing treat­ments based on thin­ner clin­i­cal tri­al da­ta, the en­tire health in­dus­try will need to fill larg­er knowl­edge gaps about how well a new drug ac­tu­al­ly works,” he said. “And RWE is one way to do so.”

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Kelly Martin, Radius Health CEO

VC firms take os­teo­poro­sis drug­mak­er Ra­dius Health pri­vate for al­most $900M

After attacks from activist investors and disappointing returns on share prices, Radius Health has now agreed to new ownership, a direction resulting in leaving the Nasdaq.

Radius Health, a biotech out of Massachusetts with one approved product in its arsenal, announced Thursday morning that it agreed to be acquired by two VC firms: Gurnet Point Capital and Patient Square Capital. The deal, worth around $890 million, will include debt assumption and the payout of $1 CVR per share for investors. And on top of that, OrbiMed is providing debt financing.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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