The Center for Biosimilars Staff

Biosimilars appear to be the only logistical solution to the rising cost of medicines, and 2 organizations in particular, the International Oncology Network (ION) Solutions and the Community Oncology Alliance (COA), have worked hard independently and on Capitol Hill to advance biosimilar-favorable legislation, according to Kashyap B. Patel, MD, a member of The Center for Biosimilars’ Advisory Board who spoke about biosimilar uptake in a recent interview.

“They both have put their full force behind supporting biosimilars,” Patel said of both organizations, in which he has been a participating member.  

Patel, of Carolina Blood and Cancer Care Associates, in Lancaster, South Carolina, said his practice is a participant in the value-base-care—centered Oncology Care Model and has chosen to adopt new biosimilars immediately after they’re approved. “We’ve assimilated them very quickly into our practice. I see biosimilars as one of the only lifetime opportunities of reducing the cost of care,” he said.

He described the assimilation of these products in his practice as substantial, although he said that it has not been easy to do this, given that payers have not uniformly opened the door to coverage of these agents.

ION is a large purchasing cooperative that has formed a biosimilars committee, which provides education for providers, payers, and pharmacists. Patel participated in the formation of that committee, but said it was challenging to teach ION members about the distinction between generics and biosimilars.

An important issue in biosimilar access is the decision process that goes into the choice of biosimilars to offer participants in a care plan. In the case of infliximab and trastuzumab, there are multiple biosimilars on the market. “ION tends to be agnostic of the manufacturer,” Patel said about the purchasing organization’s choice of biosimilars. “I think they want to work with all the manufacturers who are willing. And there’s going to be regional variation based on the payer coverage.”

ION as an intermediary works to establish manufacturer relationships and leaves it up to the physicians to decide which of the available biosimilars to use. However, “ION has chosen to go with supporting biosimilars as a part of a social responsibility,” Patel said.

COA is an organization of community oncology practices that, while not acting as a contracting representative for biosimilars and other drugs, works to promote the availability of biosimilars, Patel said. “Our role at COA is just to make sure that we bring every toolkit for our teams’ colleagues and work with the payers to help them understand the relevance of the biosimilars in addressing [Medicare] Part B drug price [issues]. We want to do everything possible we can to reduce the drug price in conjunction with the government, Senate, Congress, and payers.”

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Kashyap B. Patel, MD, has worn many hats in the struggle to broaden biosimilar access. He is an independent oncology practitioner, a member of the Community Oncology Alliance (COA), and a representative of International Oncology Network (ION) Solutions, a large drug purchasing organization. Bringing biosimilars to a broader population of patients has involved negotiations with payers, persistence on Capitol Hill, and education, he explains in an interview.

Patel: Biosimilar Education Can Be Challenging

The Supreme Court agreed Monday to a hear an appeal by a coalition of 20 mainly Democratic states, which are hoping for a reversal of a Fifth Circuit Court of Appeals ruling, which held the Affordable Care Act’s individual mandate is unconstitutional and called into question whether the remaining provisions of the law could still stand.

Among those provisions, of course, are the Biologics Price Competition and Innovation Act (BPCIA). The Department of Justice had argued that the Fifth Circuit should not only affirm that decision, but it should further find that other ACA provisions should also be struck down if the individual mandate was not severable from the rest of the statute.

Any effect on the BPCIA will hinge on the question of severability, 

In a statement, AARP’s Nancy LeaMond, executive vice president and chief advocacy and engagement officer praised the decision to review the case, 

“We urge the Court to uphold the ACA by overturning the lower appellate court’s decision,” she said. "A final ruling by the Supreme Court is needed to end years of uncertainty for millions of Americans who worry that they will lose access to critical health care coverage and essential consumer protections. It would also end the uncertainty for insurers and state and local governments who must make advance decisions each year about participating in the ACA Marketplaces and other ACA programs.”

However, a decision in the case will not come until after the November 2020 presidential election. The new term for the court does not begin until October.

There are no changes to the ACA while the case continues.

California Attorney General Xavier Becerra, leading a coalition of 20 states and Washington DC, applauded the high court’s decision. In a statement, his office said it urged the court to take up the case to “resolve the uncertainty created by the Fifth Circuit decision, which threatens the health of millions of Americans, as well as doctors, clinics, and the healthcare market.”

At issue is whether the other parts of the law can survive without the mandate; the Republican-led states, led by Texas, said that when the tax penalty was eliminated under President Donald Trump's 2017 tax cut package, it also made the ACA unconstitutional. Democratic states opposed the challenge, saying that reducing the tax penalty to zero did not eliminate the requirement.

“The Fifth Circuit correctly applied existing US Supreme Court precedent when they ruled that the individual mandate itself was unconstitutional, said Texas Attorney General Ken Paxton in a statement. “Without the individual mandate, the entire law becomes unsupportable. The federal government cannot order private citizens to purchase subpar insurance that they don’t want, and I look forward to finally settling the matter before the US Supreme Court.”

The Supreme Court will hear an appeal by a coalition of 20 mainly Democratic states, which are hoping for a reversal of a Fifth Circuit Court of Appeals ruling that held the Affordable Care Act’s (ACA) individual mandate is unconstitutional and called into question whether the remaining provisions of the law could still stand. However, a decision will not come until after the November 2020 presidential election.

Supreme Court to Rule on ACA's Fate After 2020 Election

The US Court of Appeals for the Third Circuit last week allowed 2 retail pharmacies to continue pursuing a lawsuit accusing Johnson & Johnson (J&J) of unlawfully restricting access to biosimilar infliximab while pressuring healthcare providers and payers to use its higher-priced originator product, Remicade.

 brought by Walgreens and Kroger, which alleges that J&J subsidiary Janssen “used its size and bargaining power in the broader pharmaceutical market to enter into exclusive contracts and anticompetitive bundling agreements with health insurers that suppressed generic competition to Remicade, which in turn allowed Janssen to sell Remicade at supracompetitive prices,” notes Friday’s decision.

At issue is whether the retailers have standing to accuse J&J of antitrust violations. Walgreens and Kroger had agreements with drug wholesalers, AmerisourceBergen and Cardinal Health, which in turn purchased Remicade from an affiliate of Janssen. The distribution agreement between the wholesalers and the Janssen unit contained a distribution agreement, governed by New Jersey law, barring the parties from assigning any rights or obligations under the agreement without written consent of the other party.

In 2018, the wholesalers reassigned the rights to the pharmacies, which later filed their suit. 

Janssen made the argument that under New Jersey law, the anti-assignment provision prohibited the wholesalers from assigning its federal antitrust claims against Janssen to the pharmacies, depriving them of antitrust standing.

In March 2019, the District Court granted the motion for summary judgment and ruled in Janssen’s favor on all counts, saying that Janssen was a party to the distribution agreement with standing to enforce its term.

That’s not so, the Third Circuit Court of Appeals said.

“The antitrust claims are a product of federal statute and thus are extrinsic to, and not rights ‘under,’ a commercial agreement,” the court ruled, saying that antitrust claims are not granted by the terms of a contract.

It called J&J’s arguments in the case “unconvincing."

This case is one of several J&J is facing over Remicade, which was the sole infliximab on the market until 2016. Pfizer, which launched its biosimilar infliximab Inflectra that year, is pursuing its own antitrust suit against J&J. 

 investigating the company over its conduct related to the drug.

Antitrust claims are a product of federal statute, said the Third Circuit Court of Appeals, in reinstating a Walgreens and Kroger antitrust lawsuit against J&J over its branded infliximab, Remicade. 

Appeals Court Rules J&J Must Face Infliximab Antitrust Suit Brought by Walgreens, Kroger

A new meta-analysis and review of the risk of cancer in patients with psoriasis found no increased risk found for those treated with biologics. Overall, however, patients  appear to have a slightly increased risk of cancer, particularly keratinocyte cancer and lymphomas.

The systematic review and meta-analysis, published in 

 Wednesday, consisted of 112 studies incolving over 2 million patients. Overall, the review found that the prevalence of cancer in patients with psoriasis was 4.78% (95% CI, 4.02%-5.59%), with an incidence rate (IR) of 11.75 per 1000 person-years and a risk ratio (RR) of 1.21.

As with a similar meta-analysis published in 2013, this review showed a similar link between psoriasis and cancer. The 2013 study found an association between psoriasis and cancer excluding keratinocyte cancer, keratinocyte cancer, and some solid cancers, including respiratory tract and urinary tract cancer. Besides the link with skin-related cancer, the current study found a link with bladder cancer and lung cancer. The authors noted that their analysis is larger, with twice as many studies and newer trials.

Since 2013, the use of biologics for psoriasis, which do list certain cancers as a possible adverse event, has increased, the authors said. But whether biologics have an independent risk of cancer has not been known.

The prevalence of overall cancer in patients using biologics was 3.85% (95% CI, 2.69%-5.20%). The IR was14.11 (95%CI, 10.08-18.80). The authors included 3 studies, made up of more than 12000 patients on biologics in the risk analysis. Compared with patients receiving conventional therapy, no increased risk of cancer was seen (RR, 0.97; 95% CI, 0.85-1.10).  Specifically, there was also no increased risk of cancer when looking at both keratinocyte cancer and lymphomas in patients on biologics vs conventional therapy and in fact appeared to slightly decrease when excluding keratinocyte cancer.

Overall, patients with psoriasis appear to have a slightly increased risk of cancer, particularly keratinocyte cancer and lymphomas. The cancers with the highest apparent risk for patients with psoriasis are keratinocyte cancer (RR, 2.28; CI, 1.73-3.01), lymphomas (RR, 1.56; 95% CI, 1.37-1.78), lung cancer (RR, 1.26; 95% CI, 1.13-1.40), and bladder cancer (RR, 1.12; 95% CI, 1.04-1.19).

The overall prevalence of keratinocyte cancer in patients with psoriasis was 2.55%, with an IR of 4.35 and an RR of 2.28. Results could be explained by patients with psoriasis having a high exposure to sunlight and psoralen-UV-A (PUVA) treatments. Many patients with psoriasis often spend more time in the sun and have been treated with UV-B irradiation and tar, 2 factors known to increase the risk of developing keratinocyte cancer. However, a previous study from Denmark that adjusted for cofounders, including PUVA treatments, still found a small but significant increased risk, indicating that other factors may play a role. 

Prevalence for developing all types of lymphomas was found to be 0.25%, with an IR of 0.39 and an RR of 1.56. There was a significantly higher prevalence for developing non-Hodgkin lymphoma (0.30.%) than for Hodgkin lymphoma (0.04%). 

Elevation in risk for lymphoma in part can be explained by an increased risk of cutaneous T-cell lymphoma (CTCL) in patients with psoriasis. Four of the reviews included studies did a separate analysis on CTCL and non-Hodgkin lymphoma excluding CTCL, all of which found the risk of CTCL to be highly increased for patients with severe psoriasis. Another explanation is that persistent immune activation in these patients could lead to the development of a dominant T-cell clone.

Psoriatic arthritis was not associated with an increased cancer risk, but that data is limited and needs further research, the authors said. Likewise, they wrote that future research is warranted on biologics, saying the long-term safety of these drugs is limited. In addition, the results as they pertain to biologics might be subject to selection bias, since patients using these therapies are screened and selected. 

Vaengebjerg S, Scov L, Egeberg A, Loft ND. Prevalence, incidence, and risk of cancer in patients with psoriasis and psoriatic arthritis [published online February 19, 2020]. 

The review found no increased risk of cancer when looking at both keratinocyte cancer and lymphomas in patients on biologics vs conventional therapy. Overall, however, patients with psoriasis appear to have a slightly increased risk of certain cancers.

Author | The Center for Biosimilars Staff

Patel: Biosimilar Education Can Be Challenging

Supreme Court to Rule on ACA's Fate After 2020 Election

Appeals Court Rules J&J Must Face Infliximab Antitrust Suit Brought by Walgreens, Kroger

No Higher Risk of Cancer for Patients With Psoriasis Treated With Biologics, Analysis Finds