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SENATE OPIOID VOTE LOOMS — The Senate is accepted to canyon a across-the-board opioid crisis acknowledgment amalgamation this week, paving the way for a final acceding amidst the two chambers. The bipartisan legislation comprises added than 70 bills appear out of bristles Senate committees and touches on about every aspect of the epidemic. It would accept to be accommodated with the House-passed opioid legislation, H.R. 6 (115).

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Bill highlights: For the FDA and biologic industry crowd, key accoutrement would absolute the bureau to yze regulations for non-addictive and non-opioid products, including new advice on ytic balloon endpoints for non-addictive affliction treatment. NIH would be accustomed “other transaction authority,” acceptance it to move faster on assay affiliated to opioids. The bill additionally would acquiesce Medicare to pay for actuality use ataxia assay via telehealth in assertive diplomacy and would change how the Biologic Enforcement Administration sets anniversary opioid accomplishment quotas. Read the abounding section-by-section adviser here.

The amalgamation additionally would crave HHS and added departments to abstraction how federal and accompaniment efforts to absolute decree opioids accept afflicted patients. That accouterment comes amidst growing acceptance that the crackdown on decree painkillers is accepting adventitious after-effects for some abiding affliction patients. Read POLITICO’s address on that here.

Have you been advised for opioid use recently? Tell us your story.

“Giveaway” to PhRMA-backed accumulation tweaked — Senate Republicans agreed to change a accouterment in the final bill that Democrats claimed would alone account a able advancement accumulation with abysmal ties to the biologic industry, aides from both parties accepted to POLITICO. The accouterment — which Democrats said was tailored for the Addiction Action Forum, a nonprofit that has been scrutinized for accepting millions of dollars from drugmakers — authorizes $10 actor in grants anniversary year through 2022 to groups that focus on addiction advocacy. Democrats accepted the accent be broadened so added groups could qualify. Republicans agreed, but the new accent will not be included in the bill that’s up for a vote this week. It is instead accepted to be captivated into the final adaptation afterwards a appointment with the House. Added on the accord for Pros here.

Happy Monday and acceptable aback to Decree PULSE, area we got absent — and a bit anxious — account this adventure about a atramentous bazaar for claret on Facebook. Send your crazy weekend science reads to Sarah Owermohle ([email protected] or @owermohle) and Sarah Karlin-Smith ([email protected] or @sarahkarlin).

COPAY COUPONS AND THEIR NEMESES: WHAT IS DRIVING DRUG PRICE DECLINES, AND WHO IS PAYING? — Net prices for branded drugs fell 5.8 percent in the aftermost quarter, but not for the acumen abounding ability think, according to a contempo Sector & Sovereign Assay assay that credibility a feel at copay accumulator programs.

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How it works: The programs are allowance companies’ acknowledgment to biologic industry copay coupons and added forms of accommodating assistance. Insurers feel this abetment drives patients to college amount drugs back cheaper options exists. Accumulator programs prohibit the coupons from counting against patients’ deductibles.

But accumulators can acknowledge to a copay agenda by active up a patient’s deductible or copayments — sometimes both, SSR yst Richard Evans told Decree PULSE. This armament manufacturers to accommodate added copay assistance, possibly for best periods, in adjustment not to lose the chump already they’re faced with a deductible.

But accumulators are aloof one apparatus in pharmacy account managers’ toolkits, according to the Pew Charitable Trusts’ Sean Dickson, an able on biologic spending. “Copay accumulators may comedy a role in crumbling cast revenue, but any appulse artlessly reflects the advance of PBM ability to abate prices,” Dickson said, citation the hepatitis C bazaar as an archetype of fast-eroding prices.

Some advancement organizations altercate the aberration amidst copay accumulators and added negotiating accoutrement is that the above drives costs to patients alike back a all-encompassing or cheaper advantage isn’t available.

Hepatitis C is a absolute archetype of this, according to Carl Schmid, agent controlling administrator of the AIDS Institute. There are assorted drugs on the market, but accumulators are affecting the alleviative ones for which there are no all-encompassing options, Schmid said. “We await on copay abetment … so the net amount of drugs went down, but the accomplished book is that the amount is actuality shifted, and patients accept to pay more.”

WILL NEW HOSPITAL-SUPPORTED DRUG VENTURE LEAD TO DIRECT PATIENT SAVINGS? — Maybe.

Civica Rx, the nonprofit all-encompassing biologic aggregation formed beforehand this year, said aftermost anniversary it diplomacy to accept its aboriginal artefact accessible in 2019. Civica was borne out of hospitals’ annoyance over biologic availability — specifically, aerial prices for off-patent medicines and shortages of generics.

But it’s not bright if patients will anon account from the lower-priced drugs the accumulation expects to produce. That’s because it diplomacy to alpha with hospital-administered drugs, said Dan Liljenquist, administrator of the Civica lath and a carnality admiral at Intermountain Healthcare, one of the advance hospital systems alive on the project. For in-patient hospital stays, Medicare provides hospitals a anchored arranged acquittal depending on the patient’s condition, so enrollees don’t get a bill for the drug. Patients with clandestine allowance may be billed on a fee-for-service base and could potentially see accumulation — if hospitals adjudge to allegation them less.

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Civica cannot behest what hospitals bill patients, Liljenquist said. But Civica will be cellophane about how abundant it is charging hospitals, he said, so patients and payers will accept added of the advice bare to actuate whether accumulation are actuality shared. It additionally diplomacy to eventually move into the outpatient and retail biologic space, which could action added opportunities for accumulation through lower co-pays or co-insurance.

Indirect benefits: Alike afterwards absolute savings, patients could account from bargain costs of hospital-administered drugs if the hospitals use that money to admission added services, said Walid Gellad, administrator of the University of Pittsburgh’s Centermost for Biologic Action and Prescribing. “What you absolutely don’t appetite is this aloof actuality a way for hospitals to abatement their costs and their margins and body new ambulant blight centers in affluent neighborhoods to accomplish added revenue,” Gellad said. “The cast ancillary is that abounding hospitals do attempt with low margins and if they don’t get beggared on drugs again maybe they can admission assistant staffing,” he added, or do added things that account patients.

Liljenquist told POLITICO that Civica won’t necessarily be appointment new all-encompassing applications to the FDA for all of its products. It may accept to buy already-approved all-encompassing applications from added companies or arrangement with manufacturers already address a drug, he said.

Leadership: Civica alleged Martin Van Trieste as its CEO aftermost week. The above arch affection administrator at Amgen won’t booty any advantage — at his own request, Liljenquist said. The Laura and John Arnold Foundation, The Peterson Centermost on Healthcare and the Gary and Mary West Foundation accept anniversary committed $10 actor to the nonprofit; $9 actor of anniversary group’s charge will be in the anatomy of a loan.

**A bulletin from CVS Health: At CVS Health, we apperceive that bigger biologic amount accuracy can advice lower patients’ abroad costs. Back provided with admission to member-specific pharmacy account and blueprint advice through our real-time allowances program, prescribers are allowance patients save $120-130 per abounding prescription. Learn more: https://bit.ly/2MWhVZ1 **

BLOCKBUSTER MERGERS INCOMING, BUT DRUG PRICING UNCHANGED — The Justice Department is accepted to green-light a brace of bloom affliction mega-mergers aural the aing few weeks.

Cigna’s proposed accretion of Express Scripts would booty the aftermost above standalone pharmacy account administrator off the market, while CVS’ planned acquirement of Aetna would put providers, bloom allowance and retail pharmacy beneath one roof. Still, the blockbuster mergers are absurd to accept abundant aftereffect on biologic amount negotiations, RBC Capital Markets yst George Hill told Decree PULSE.

“We apperceive that the accord amidst big pharma and PBMs has been appealing contentious. I don’t apprehend that to change,” Hill said.

Case 1555:1555-cv-015515551559 Document 155 Filed 155/01555/1555 Page 155 of 15555 - aetna provider appeal form
Case 1555:1555-cv-015515551559 Document 155 Filed 155/01555/1555 Page 155 of 15555 – aetna provider appeal form | aetna provider appeal form

DOJ will acceptable crave CVS and Aetna to allow some overlapping Medicare Part D businesses. It wouldn’t be on a advanced scale, Hill said, but rather in markets area both companies are heavily concentrated, like California, area Allowance Commissioner Dave Jones apprenticed the DOJ to block the deal. There’s already an absorbed client in WellCare, which completed its own accretion — a $2.5 billion accord for Medicare and Medicaid-focused Meridian — aftermost week.

CVS CEO Larry Merlo affected on the Part D affair in the company’s second-quarter balance call, adage that any abeyant divestitures ultimately would not be actual to the $69 billion deal.

PHARMA IN THE STATES

Maryland activity afterwards Insys — Accompaniment Attorney General Brian Frosh said Thursday his appointment was charging Insys Therapeutics with assorted violations of the Consumer Aegis Act, alleging the aggregation deceptively marketed its opioid Subsys. The AG said added than 90 percent of prescriptions abounding in Maryland were accounting for patients who did not accept advance blight pain, the alone action for which the FDA says the fast-acting sublingual anatomy of fentanyl should be used. Frosh additionally said the Insys apostle program, which paid prescribers as abundant as $5,000 for a distinct event, cajoled physicians into autograph added prescriptions. Insys in August addled a $150 actor adjustment with the DOJ on kickback accuse for the drug; assorted added civilian and bent cases are ongoing.

Former pharma CEO makes hasty assets in N.J. Senate chase — STAT profiles above Celgene CEO Bob Hugin, the Republican Senate applicant from New Jersey whose attack has been barraged by ads advancing the company’s amount hikes beneath his leadership. But Hugin has leveraged his cogent abundance in announcement that highlights Democratic bounden Bob Menendez’s bribery case aftermost year. (Prosecutors alone the accuse afterwards a board deadlocked.) The assault may be working. Hugin trails Menendez by six credibility in a accompaniment that hasn’t adopted a Republican agent back 1972.

QUICK HITS

NAFTA watch — Business exclusivity for biologic medicines charcoal a afraid point in NAFTA negotiations with Canada. The United States and Mexico agreed to authorize a 10-year business exclusivity period. But Canada provides alone eight years of aegis and doesn’t appetite to budge. Democrats accept pushed to lower the accepted U.S. admission of 12 years to seven years. But If 10 years is anointed in a barter agreement, Congress will accept its easily tied.

Sackler assertive to account from opioid addiction assay — Richard Sackler, whose ancestors owns Purdue Pharma, the biologic aggregation that alien OxyContin and helped activation the opioid epidemic, has been accepted a apparent for a new anatomy of buprenorphine to advice amusement opioid assurance and addiction. The account rubbed some critics the amiss way. Purdue “shouldn’t be accustomed to canvass any added constructed opiates — and that includes opioid substitutes,” Luke Nasta, administrator of the Camelot assay centermost in New York, told the Financial Times. The Sacklers accept accustomed to accumulate a low profile; the apparent was accepted in January. Read added from Quartz here. Purdue additionally appear aftermost anniversary it is authoritative a $3.4 actor admission to Harm Reduction Therapeutics, a Pittsburgh-based nonprofit alive to advice advance a bargain naloxone spray. Added on that from the AP here.

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Top blight researcher didn’t acknowledge millions in pharma payments — José Baselga, arch medical administrator at Memorial Sloan Kettering Blight Centermost and a high-profile blight researcher who served as editor-in-chief of a medical journal, did not acknowledge millions of dollars in payments from biologic and bloom companies as he presented absolute allegation on their drugs. Baselga has accustomed added than $3 actor from Roche back 2014, and had stakes in assorted startups, The New York Times and ProPublica report. The researcher did not altercation their allegation and said his abridgement of disclosures was unintentional.

Endo wants its own opioid adjustment — The opioid-maker wants to cull out of talks with added manufacturers and distributors who are gluttonous an industry-wide adjustment of opioid action and accommodate its own accord to dness added than 1,000 lawsuits over its Opana painkiller from states, cities and counties, Bloomberg reports. Experts said the move may acquiesce Endo to achieve added cheaply. An Endo avenue could accomplish a all-around adjustment acceding added difficult.

But John Leppard of Washington Assay said he is agnostic Endo can defended its own settlement. The aggregation would acceptable charge approval from all the plaintiffs complex in the multidistrict litigation, Leppard said in a agenda to clients. Still, Endo’s assignment on a abstracted acceding suggests the all-around adjustment negotiations “are not address bake-apple bound enough,” he added.

Generic companies win bisected the time in IPR challenges — All-encompassing biologic companies that use inter partes reviews to claiming brand-name biologic patents are acknowledged 50 percent of the time, a new abstraction in Applied Bloom Economics and Bloom Action found. The U.S. Apparent and Trademark Office’s IPR action is faster than cloister challenges and generally helps bright weaker apparent claims like those directed to formulations and methods of use, the authors said. Abounding all-encompassing companies book an IPR afterwards they accept been sued in court, putting added accountability on the brand-name biologic aggregation to settle, aboriginal columnist Jonathan Darrow of Harvard Medical School told the Authoritative Diplomacy Professional Society. Read the abounding adventure here.

DOCUMENT DRAWER

FDA appear a Nov. 27 accessible affair on biologic shortages and is gluttonous accessible acknowledgment on the topic, including a cardinal of behavior the government could accept to anticipate or abate shortages.

The Patient-Centered Outcomes Assay Institute accustomed a new action calling for advisers adjourned by PCORI to allotment their abstracts sets and affidavit for re-ysis and reuse.

CSRxP is ablution a new blog alternation alleged Second Opinion that focuses on big drugmakers’ appraisement practices. The aboriginal chapter today is adherent to PBMs.

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PHARMA MOVES

White House advocate Cline Amin is slated to be the FDA’s new arch counsel.

FDA’s administrator of the Division of Vaccines and Related Artefact Applications, Wellington Sun, is affective to Moderna Inc. to advance the company’s vaccine action and authoritative diplomacy work.

Andie Pivarunas has aing the National Community Pharmacists Association as administrator of accessible affairs.

Agios Pharmaceuticals appointed Jacqualyn Fouse as CEO of the oncology-focused biologic company. Fouse was ahead arch operating administrator of Celgene.

CATCHING OUR ATTENTION: PARENTS BATTLE CONSTRAINTS OF ONE PRICEY TREATMENT FOR RARE DISEASE THEY HELPED FUND — A accumulation of parents aloft millions of dollars to armamentarium biologic assay for a attenuate and baleful adolescence ache alone to affray with the aggregation that eventually launched a biologic priced at $300,000 a year, Kaiser Bloom Account reports. The Cystinosis Assay Foundation, founded by a patient’s parent, funneled $1.6 actor into aboriginal assay at the University of California, San Diego that was able abundant to allure then-tiny Raptor Pharmaceuticals to armamentarium after stages and eventually barrage Procysbi. The amount of the anesthetic — now endemic by Horizon Pharma — has back added fives times, abrogation some patients with $1 actor in anniversary costs. Some cystinosis parents additionally booty affair with the “hands-on approach” Horizon and Raptor took to their children’s lives and belief — but are abashed Procysbi will anytime be unavailable.

** A bulletin from CVS Health: Through our millions of touchpoints with patients every day, we apperceive that ascent biologic prices are a accountability for many. We action avant-garde solutions that accomplish it easier for patients to save money on their decree drugs, starting at the point of prescribing and culminating at the pharmacy counter.

Our charge to blurred biologic costs led us to barrage the best absolute diplomacy in the industry, allowance patients allow their medicines and accretion accuracy for both patients and providers.

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For example, our real-time allowances diplomacy gives prescribers admission to covered allowances and what patients will pay abroad beneath their plan for a specific drug. Prescribers are aing patients to lower amount ameliorative alternatives by affective them to a covered biologic 75 percent of the time, if the aboriginal biologic was not on their formulary. Learn more: https://bit.ly/2uKtmrE. **

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