Lenalidomide Plus Rituximab Chemotherapy for Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas

Data from 2 randomized controlled trials indicated a statistically significant benefit in progression-free survival and overall survival for patients with follicular lymphoma who received R2 as compared to patients who received rituximab plus placebo or R-CHOP. The frequency of all types of adverse events in patients receiving R2 as compared to rituximab plus placebo or R-CHOP was comparable, but patients receiving R2 experienced more severe adverse events. Two economic analyses concluded that R2 was cost-effective for the treatment of patients with follicular lymphoma as compared to rituximab plus placebo (UK and Dutch contexts). Evidence identified in this review was mostly limited to that describing patients with follicular lymphoma. Most evidence identified in this review was generated with support and/or funding from a private industry pharmaceutical manufacturer.

Regenerative Medicine in South Korea: Bridging the Gap Between Authorization and Reimbursement

Regenerative medicine (RM) has considerable potential to address the needs of aging-related and uncurable diseases. However, its incorporation into reimbursement of health insurance benefits poses many challenges, including uncertain evidence and insufficient investment. This paper examines the wide gap between manufacturers, regulatory bodies, and health technology bodies regarding reimbursements for RMs focused cell therapy products. In this mixed-methods study, we first analyzed the sales of RMs approved in South Korea. In addition to exploring beliefs related to the market value of RMs, in-depth interviews were conducted with 24 experts (17 from bio-industries, two from the regulatory body, three from a health technology assessment (HTA) body, and two from the Pharmaceutical Benefit Coverage Assessment Committee [PBCAC]). Lastly, we surveyed PBCAC members about the market value of RMs. In total, 15 of the 20 developed cell therapy products are on the market in South Korea, and amounted to 0.24% of total pharmaceutical expenditures in 2018. We identified a wide gap between stakeholders and regulators regarding the market value and pricing of RMs. The interviewees from the pharmaceutical manufacturer association raised the issue of rising manufacturing costs and proposed a specific pricing policy for RMs. To bridge the gap between approval and reimbursement, stakeholders demand an alternative framework of value-based pricing. Conditional health insurance reimbursement may be an alternative to the traditional process in order to generate evidence of the effects of RMs using “risk-based” or “outcome-based” approaches.

Comparison of generic drug registration strategies between health Canada and Gulf Cooperation Council

Recently, generic drug products have played an increasingly important role in the health care system globally, especially in the developing world, as they provide for an effective and more affordable alternative for healthcare professional. Generic drug products are proven therapeutically equivalent to the corresponding innovator’s product, and hence can be substituted in clinical practice. The Gulf Cooperation Council’s pharmaceutical market is known to be semi-regulated market when compared with Health Canada and the United States of America drug regulatory market. Product regulation in Gulf Cooperation Council and Health Canada are challenging task in comparison to EU and USA. This study aimed to understand the generic drug registration comparison of Health Canada and Gulf Cooperation Council’s. The aim of this study was achieved by review of the Health Canada and Gulf Cooperation council guidelines and publications. Health Canada and Gulf Cooperation council follows Common Technical Document format and also emphasizes on safety, quality and efficacy of the drug. In summary Gulf Cooperation council and Health Canada offers lucrative market for Indian pharmaceutical manufacturer and the process of registration has been simplified by centralized procedure.

The Cost and Evolution of Quality at Cipla Ltd., 1935–2016

This article examines the evolution of Indian pharmaceutical manufacturer Cipla toward producing drugs that met the quality standards of European and U.S. regulators. It employs new research in both Cipla's corporate archives and a wide range of oral histories. The article argues that, along with a long-standing corporate culture of self-reliance rooted in nationalism starting from the company's inception in 1935, major factors in Cipla's strategy from the 1960s through the early 2000s included the early adoption and continued use of quality-control technology, along with efforts to create global goodwill for affordable high-quality generic drugs during the HIV/AIDS epidemic of the early 2000s.

Price Cap Models in Pharmaceutical Online-to-Offline Supply Chains

Pharmaceutical supply chains are often highly complex with conflicting objectives of social welfare and profit maximization. Furthermore, there are various stakeholders including pharmaceutical manufacturer, distributors, retailers, patients, and the government. In this paper, we consider a two-stage supply chain consisting of one pharmaceutical manufacturer and a pharmacy with online and offline channels. We focus on four price cap models: no price cap regulation, pharmaceutical manufacturer’s price cap regulation, pharmacy price cap regulation, and linkage price cap regulation. We apply game theory, investigate how the price cap regulations affect the firms’ pricing, and evaluate the economic performance and social welfare of the dual-channel pharmaceutical supply chain. Our findings show that first, like the single-channel pharmaceutical supply chain, the profit of the regulated firm always decreases and the profit of the unregulated firm always increases when they are under one-sided price cap regulations. Second, the impacts of the linkage price cap regulation on the supply chain are more complicated depending on the linkage coefficient and market share. Overall, our findings can provide theoretical and practical insights to help the government devise price cap regulations for complex modern pharmaceutical supply chains.

ICU Pharma Pakistan: Growth Crossroads

Growth from a small-scale venture to a medium-sized company entails different challenges and strategies to tackle them. This case provides an account of one such company operating in the pharmaceutical sector of Pakistan. International Collaborated Unit Pharma (ICU Pharma) started in 2005 in the small town of Dera Ghazi Khan, in the province of Punjab, as a distributor of Ferozsons (Private) Ltd, a leading pharmaceutical manufacturer in Pakistan. Going through various phases of growth and strategic shifts, it had become a well-established company by 2019, with PKR 200 million net worth and a sales network covering thirty-four districts in Punjab, Khyber Pakhtunkhwa and Sindh provinces. In 2018, the company faced a growth dilemma when, despite the growing demand for its products, it had to curtail sales growth and divert resources towards building a manufacturing facility in Lahore. This case illustrates how industry growth, country-level initiatives for the implementation of Sustainable Development Goals on Health (SDG No. 3), policies of the Drug Regulation Authority of Pakistan (DRAP), weak contract enforcement in Pakistan and threats from suppliers, along with other external forces, constrained a company’s decision to opt for a backward integration strategy instead of going for the more plausible strategy of product and market development.

624. Significant Institutional Cost Savings from OPAT-Facilitated Discharge for Patients with Challenging Situations

Background Outpatient parenteral antimicrobial therapy (OPAT) programs are becoming a standard of care, however, program cost justification remains a challenge. One area of focus for institutions is facilitating timely discharge from the inpatient setting, and difficult to discharge patients are a group with which OPAT teams can be particularly impactful. Methods This retrospective review identified patients intervened upon by the Nebraska Medicine OPAT team during the initial nine months after program implementation (4/1/19 - 12/31/19) for which routine efforts at discharge by primary teams had failed. Patients were planned for extended inpatient stays to complete the full duration of parenteral antibiotic therapy due to discharge issues given the therapy plan initially recommended by infectious disease consult teams. Outcomes evaluated included inpatient days of therapy avoided, associated financial metrics, and 30-day readmission rates. A matched cohort of patients with similar lengths-of-stay, infectious disease indications, medication use, and lack of major complications was identified to calculate a cost per inpatient day avoided. Results A total of 17 difficult to discharge patients were intervened on by the OPAT team, leading to avoidance of 429 planned inpatient days. Based on calculation from internal matched cohort data, these OPAT interventions avoided an estimated $943,000 in total inpatient costs. All-cause 30-day readmission was 24% (4 of 17 patients). Additionally, 15 of these therapy courses were shifted to hospital-associated outpatient infusion centers. Facilitation of enrollment for 11 of these patients in pharmaceutical manufacturer patient assistance programs resulted in replacement of outpatient medication totaling over $28,000 in value. Reimbursements for two additional patients through either governmental or private insurance generated over $11,000 in margin for the health system. Conclusion Attention to complex discharge facilitation by OPAT programs can be a significant contribution to program cost justification, while also transitioning patients to therapy plans that lead to similar clinical outcomes when compared to the overall OPAT population. Disclosures All Authors: No reported disclosures

Prescription of memantine/donepezil

High prescription costs in industrialized countries, and foremost the U.S., are due not only to high development costs but to the pricing policy for patented medical products. The reformulation of existing molecules and the combination of existing drugs can have, in addition to a medical benefit, the advantage for the pharmaceutical manufacturer that market shares are maintained or even gained. While many new brand-name drugs have a clear medical benefit, there are also drugs and combinations that have so far been unable to demonstrate any additional benefit. Moreover, it is usual for such reformulations to come onto the market at a price many times higher than that of existing generics.1

Comparison of Regulatory Requirements for Filing Drug Master File (DMF) in Emerging Markets - China, Brazil & South Korea

Background: A DMF consists of confidential information, usually related to Chemistry, Manufacturing and Control (CMC) of the drug substance. DMF is prepared and submitted by the pharmaceutical manufacturer solely to the regulatory authority of the respected country where he wants to market. Objective: Compare the regulations of the emerging markets with that of a regulated market and to highlight the stringent requirements imposed by emerging authorities. The similarities and differences of the requirements for filing a DMF in emerging markets are compared against the regulated market. Methods: The method carried out for every single study follows some patterns and certain pathways in order to reach its target. Method begins with scope and objective of regulatory perspective of DMF filing requirements for USA, China, Brazil and Korea. The information was collected from Regulatory authorities, Legislations, Guidelines and Experts opinion. Results: Regulatory requirements for filing a DMF for API registration vary from country to country. Even though a standard ICH-CTD format is available and most widely followed, there are some specific requirements recommended by drug authorities which are mandatory to be provided while filing to that particular country. Conclusion: Based on the current study it is clear that emerging markets possess more stringent requirements for API approval as compared to the regulatory market but the dispute is that the emerging markets do not have harmonized guidelines and are not transparent enough.