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Indivior’s Sublocade Idea Proposal (INDV)

Indivior’s Sublocade Idea Proposal (INDV)
 

Is the launch of Indivior’s Sublocade on track? Is the treatment community ready to adopt Sublocade?

Report Available: July 12, 2018

 

Blueshift’s initial research found INDV highly optimistic about its recently approved drug Sublocade, a monthly injection of buprenorphine used to treat Opioid Use Disorder (OUD). The product is in the early stages of launch and INDV said it is preparing for substantial uptake. As with all new drugs, challenging the standard of care is a significant task. The logistics of use and stringent DEA regulations are additional hurdles potentially impeding widespread adoption of Sublocade.

 

Observations

  1. On November 30, 2017 the U.S. Food and Drug Administration approved the first monthly buprenorphine product for the treatment of OUD. Sublocade is a drug-device combination product that uses buprenorphine and the Atrigel Delivery System in a pre-filled syringe. It is administered subcutaneously to patients who have initiated treatment with a transmucosal buprenorphine-containing product and who have been on a stable dose of buprenorphine for a minimum of seven days. The approval does contain a Black Box warning against intravenous self-administration and includes a statement that Sublocade must be prescribed and dispensed as part of a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the product is not distributed directly to patients.
  2. During INDV’s Q4 earnings call on January 21, the company highlighted Sublocade’s technology and promoted it as a transformational product in the treatment of OUD. Access to treatment for OUD in the U.S. continues to expand and the Medication-Assisted Treatment (MAT) market is expected to grow double-digits in 2018. INDV forecasts Sublocade sales at more than $1 billion over time. Production continues to ramp up and INDV’s sales force is trained and heading into the treatment community to engage with treatment providers. First adopters of Sublocade are expected to be prescribing the treatment throughout March. Product deliveries will take about a month and first patients will be returning to their physicians in May for their second injection. The bulk of Sublocade’s sales are expected to occur in the second half of 2018.
  3. Sublocade uses a buprenorphine formulation which has a proven track record of helping people abstain from the addictive use of opioids. Professionals and patientsare eager touse the new treatment, calling it a potential game changer in the fight against opioid addiction. Both groups have high expectations that the new drug will become the standard of care with improved compliance and clinical outcomes, less diversion and relapses, improving the overall quality of life for patients and the community.
  4. There are also those in the treatment community that are more cautious in their outlook on Sublocade, acknowledging that the drug is a positive step in fighting the addiction epidemic, but also pointing out the significant challenges that must be navigated to establish widespread adoption. Introducing Sublocade too early in the recovery process when the patient may need frequent medication adjustments that are not possible with the new drug could derail the recovery process. The monthly injection could curtail a patient’s desire to engage in therapy, an important part of recovery. Abuse of other drugs or alcohol while on Sublocade are additional pitfalls. Also, the logistics of ordering, handling, and administering a monthly injection from specialty pharmacies, as well as increased DEA regulations may deter potential prescribers from getting involved. Receiving approval from payers and insurance companies is another requirement for success.
  5. In a preliminary interview this week with Blueshift Research, a program director at a West Coast addiction recovery center said that Sublocade will be a much more cost effective treatment when compared to the Braeburn/TTNP $20,000 six-month implantable Probuphine compared to $1,600 a month for Sublocade. The source said Sublocade will also be superior to Suboxone, the current treatment standard, with regard to eliminating or reducing diversion. He added that if insurers back the use of Sublocade, it could achieve INDV’s sales goals of more than $1 billion in sales.
  6. Blueshift’s March 2, 2017, report on not-yet approved long-acting buprenorphine products found that INDV’s RBP-6000, now called Sublocade, and CAMX/Braeburn’s CAM2038 were expected to have a significant effect on the MAT market for OUD. Both products performed well in trials and sources said they could be available by early 2018. Sources were highly interested and excited about these products because of their potential to prevent diversion, suitability for a wide patient profile, higher dosage offerings, reliance on injections rather than implants, competitive pricing, and likelihood to be more appealing to third-party payers. This was a continuation and advancement of the trends found in Blueshift’s April 8, 2016, report, which found that long-acting implantable and injectable buprenorphine was expected to become an important tool and gain a significant foothold in treating opioid-addicted patients over time.

 

How is the Sublocade launch progressing? What do physicians and medical professionals think about the logistics of prescribing, ordering, handling and administering Sublocade? What is the patient profile that is appropriate for Sublocade? What are physicians’ expectations for treatment compliance? What are third-party payers planning/saying regarding Sublocade? Is INDV’s Sublocade launch gaining traction with the OUD treatment community? Are patients asking about Sublocade? Is there any early feedback about Sublocade? What do early adopters and non-adopters think about Sublocade? What will motivate non-adopters to prescribe Sublocade? To answer these and other questions, Blueshift will gather data and issue a market research report from independent sources in the following areas: Medical professionals, Third-party payers, Opioid addiction treatment sales channel, Addiction treatment professionals, and Industry specialists.

 

Companies:Alkermes plc (ALKS), Camurus AB (STO:CAMX), Indivior plc (LON:INDV),Orexo AB (ORXOF),Teva Pharmaceutical Industries Ltd. (TLV:TEVA), Titan Pharmaceuticals Inc. (TTNP)

 

Research Begins: June 25, 2018

 

Are you aware Intro-act, our corporate access solution, is part of the Blueshift Research ecosystem? To learn more, go toIntro-act.comor check out our video suite.