Drashti – RGA6463 Case Study #1 Assignment.pdf
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BKK CASE STUDY 1 BKK: A breakthrough therapy Drashti Patel Northeastern University College of Professional Studies
BKK CASE STUDY 2 BKK: A breakthrough therapy Overview of BKK case In the wake of opioid crisis, Dr. Worthington developed an anesthesia known as BKK with an intend to reduce opioid exposure and spent his entire life on training personnel on how to use the drug. Even though drug had benefits, he faced several struggles during BKK development and marketing from regulatory perspective and finally partnered with Ballard to commercialize it in 2018. This case study write-up describes the events considering the struggles faced by Worthington to enter the market with best strategy. How opioid crisis lead to development of BKK? Since past decade U.S. is experiencing escalation in opioid epidemic due to high availability, and overdose. Based on the literature, exposure to opioids in the hospitals for pain-
management has led to increase in addiction rate, associated hospital-care cost, and mortality, making it a hospital-acquired condition(Gupta et al., 2018, pg. 881; Lyden & Binswanger, 2019). Due to these reasons, it was mandatory to develop an FDA-approved drug that can address the opioid crisis in U.S. Thus, Dr. Worthington eventually began the discovery of a non-opioid drug using combination of FDA approved drugs available to him. In 2000, Dr. Worthington developed an opioid sparing, local anesthesia drug using three FDA approved drugs- Bupivacaine, Ketorolac and Ketamine working in synergy using multimodal analgesia approach to mitigate pain and reduce use of opioid known as BKK (Bhatia & Buvanendran, 2019). He also developed “DREAMS”, a program to manage opioid cases.
BKK CASE STUDY 3 The indication of use is to alleviate post-operative pain and inflammation at the surgical site for up to 40 hours, along with preventing nausea to reduce and eradicate use of opioid painkillers in patients who has undergone either general or complicated surgeries such as spine. According to Brown et al. (2020), perioperative administration of multimodal analgesia helps to reduce opioid use for pain management, in-patient hospital stays & adverse effects without affecting pain level which supports evidence presented for BKK to reduce average length of stay (LOS) to few hours after surgery (pg. 6). Stake holders involved in commercializing are doctors, medical staff, medical representatives, patients, buyers, insurance payers, health authorities and pharmaceutical companies(Kramer & Greek, 2018). Challenges for Dr. Worthington Till 2005, he improved the SOPs for opioid-free protocols along with, implemented USP-
797 compliance procedure for BKK to ensure safety & efficacy and decrease LOS to few hours even for complicated surgeries which demonstrated the efficiency of the facility which resulted in widespread usage of BKK(Baek et al., 2018). In 2012, NECC disaster occurred due to fungal contamination of spinal injectable compound which caused fungal meningitis outbreak. This event elicited 503B law regulating compounding pharmacy for manufacturing, marketing, and distributing(Quertermous J, 2018). Therefore, considering safety and accountability, he decided to collaborate with a 503B compounding pharmacy rather than admixing in hospital facility during which he had a thought to market BKK. In 2013, Worthington filed a provisional patent however, in late 2017 when patent was about to publish, Worthington’s ownership of BKK and its protocol was derogated due to mention
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BKK CASE STUDY 4 of BKK in a blog, dated 2004. As stated in research, a continuation for patent can be filed based on experimental exemption which permits R&D using of patented products(Patil, 2020). Due to the roadblock, Worthington filed a continuation. After that they collaborated with a compounding pharmacy to manufacture and pitched AngelHealth for marketing and distribution of BKK to meet Medical Leaders in Healthcare’s (MLH) requirement. However, they were unable to market BKK as no agreement was signed due to delayed communication with regarding production. In addition, marketing approach failed as FDA proscribed the use of sales representatives for promoting a compounded drug which is the best strategy to increase the market and profit(Eisenberg et al., 2020). In 2018, he was Owner of BKK patent which protected the composition, admixing & administrating procedures based on the data accumulated for years. But he didn’t rece
ived patent as a new drug as it requires an NDA approval which takes approximately two years and cost millions with significant facility resources for product safety, efficacy, and quality to complete the process (Norman, 2016, pg. 174) How to commercialize BKK- a tough decision After patent publication, Worthington and Ballard decided to commercialize BKK but since drug development process and commercialization is a time-consuming requiring significant funds and maintenance of regulatory norms, they decided to contemplate different paths by evaluating risks and benefits associated with each route (Chen et al., 2018). The two paths from a regulatory perspective to market BKK were - (1) Getting an expedited NDA approval as a break-through therapy based on the unique anti-nausea effects, (2)
BKK CASE STUDY 5 Manufacturing BKK as combination drug or, convenience kit to avoid FDA approval despite of following regulations(BKK, 2019). A SWOT analysis technique can used to determine 4 factors of the organization: Strength(S) and Weakness(W), Opportunities(O) and Threats(T)(Eizaga Rebollar et al., 2020). For the first path, partnering with an investor will help to get an NDA approval and resources(O) which will provide additional patent protection, support for production with expected annual growth rate of 36% & $32 cost/dose(S). However, in return of equity funds, Worthington will have only 35% ownership(W) and it will take months for an expedited NDA without guaranteed approval which will affect first mover advantage(T) as three competitor drugs are expected to be marketed in the same duration. Therefore, the chance of successful marketing is only 50%(BKK, 2019). In the second path, they decided to collaborate with a new compounding pharmacy which will produce and market BKK within the start-up time of three months(O) with no additional cost as its sale will be directly to the facility. The cost per dose will be $16 and year-to-year growth rate of less than 10%(S). However, Worthington must bear huge up-front cost including legal cost and manufacturing facility set-up cost(W). Although based on the risks, the success ratio of this path is 85%(BKK, 2019). In the third path, they decided to market BKK as a convenience kit which will contain the three drugs bottled individually in a proper dosage with an instructional manual. This pathway has many benefits such as longer shelf-life of drugs, no up-front cost to Worthington as facility will be well-equipped, Worthington will have right to control selling price and it will require only four months to set-up the production line with growth rate per year to be 20%(S). Also, since kit is not
BKK CASE STUDY 6 a combination product, it is not subjected to FDA regulations for compound drugs which will facilitate B2B marketing with success of 75%(O). While high cost/dose was only risk due to as competitive market(BKK, 2019). However, Worthington shouldn’t be anxious about the competitive landscape because there are several drawbacks of other drugs despite of their long-lasting effect. Firstly, most of the drugs were expensive. Secondly, Exparel had variable effect in reducing pain as compared to BKK. Lastly, HTX-011 has limited clinical use as it cannot be administered for spinal and neck surgeries as its safety and efficacy is not determined(BKK, 2019). Thus, the most optimum path to bring BKK into U.S. market after considering SWOT analysis and competitive landscape is “Convenience Kit” as it is the one stop solu
tion. As compared to other paths, the benefits outweigh the associated risk in terms of up-front cost, timeline to produce BKK and expected growth rate.
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BKK CASE STUDY 7 References Baek, H., Cho, M., Kim, S., Hwang, H., Song, M., & Yoo, S. (2018). Analysis of length of hospital stay using electronic health records: A statistical and data mining approach. PLoS ONE
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