How Will Physicians and Payers Value Advances in Drug Delivery?

Opioid addiction is a debilitating, chronic relapsing disorder affecting nearly 5 million people in the seven major markets under study (United States, France, Germany, Italy, Spain, United Kingdom, and Japan). The buprenorphine/naloxone sublingual film (Reckitt Benckiser Pharmaceuticals’ Suboxone) was the patient- and market-share leader in 2012 owing to its familiarity to physicians and lack of administration restrictions compared with other opioid replacement therapies. Additional buprenorphine/naloxone formulations and the buprenorphine implant (Titan Pharmaceuticals/Braeburn Pharmaceuticals’ Probuphine) will offer delivery advantages over existing products; however, with limited drug development in opioid addiction, our surveyed psychiatrists and payers agree that significant opportunity remains for therapies that can offer improvement in reducing the use of opioids, as well as the risk of misuse, abuse, and diversion in this difficult-to-treat population.

Questions Answered in This Report:

  • Reduction in the use of opioids and retention of patients on pharmacotherapy are key goals in the treatment of opioid addiction. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European psychiatrists weight specific efficacy end points and other drug attributes in their prescribing decisions for opioid addiction?

  • The buprenorphine/naloxone sublingual film is the 2012 major-market sales leader for opioid addiction. What weaknesses in its profile would allow emerging therapies to gain a foothold in the market? Have emerging therapies demonstrated potential on the attributes that surveyed psychiatrists indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that managed care organization pharmacy directors (MCO PDs) seek from new therapies?

  • Risk of abuse, misuse, and diversion and price per treated day are key drivers of physicians’ prescribing decisions. What trade-offs across these and other clinical attributes are U.S. psychiatrists willing to make when considering the use of emerging therapies for the treatment of opioid addiction? Based on the trade-offs in price and performance across key drug attributes that U.S. psychiatrists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for opioid addiction?

  • By 2017, the buprenorphine implant will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is the buprenorphine implant most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by the buprenorphine implant?

Scope:

Attributes included in conjoint analysis based assessment of target product profiles for opioid addiction:

- Percentage of urine samples negative for illicit opioids over placebo during the study period.

- Percentage of opioid-dependent patients completing the study over placebo.

- Reduction in patient-rated craving for opioids from baseline over placebo.

- Risk of abuse, misuse, and/or diversion.

- Change in Subjective Opioid Withdrawal Scale score during study period over placebo.

- Dosing frequency.

- Price per treated day.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for opioid addiction:

- Greater reduction in the use of opioids.

- Increased retention of patients on pharmacotherapy.

- Lower risk of abuse, misuse, and diversion.

- Improved dosing frequency.

Physicians surveyed: 61 U.S. and 30 European psychiatrists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Buprenorphine/naloxone sublingual film (Reckitt Benckiser Pharmaceuticals’ Suboxone)

- Buprenorphine/naloxone sublingual tablet (Orexo’s Zubsolv)

- Methadone (Roxane’s Dolophine, Mallinckrodt’s Methadose, other brands, generics)

- Naltrexone oral tablet (Teva’s ReVia, Bristol-Myers Squibb’s Nemexin/Nalorex, Lacer’s Celupan, Merck & Co.’s Nalorex, Zambon’s Antaxone, Britannia Pharmaceuticals’ Opizone, Sirton Pharmaceuticals’ Narcoral, generics)

- Naltrexone depot (Alkermes’ Vivitrol)

Emerging Therapies

- Buprenorphine implant (Titan Pharmaceuticals/Braeburn Pharmaceuticals’ Probuphine)

- BEMA buprenorphine/naloxone (BioDelivery Sciences International’s Bunavail)