- Evaluation of a drug label including patient reported outcomes (Limit 2 pages)The evaluation of the PRO will include the following information:a) Company, generic, brand name and therapeutic class of the product
Brand name: HUMIRA
Generic name: adalimumab
Therapeutic class of the product: Antirheumatic
b) AHFS or other Drug Classification
AHFS: 92.00
c) FDA Approved Indication
Humira got FDA approval in the year 2002
e) Identity the type of studies that were conducted by the pharmaceutical company to support the PRO claims.
e.1. Trial design, randomization and blinding procedures
Ans: Mostly randomised clinical trials were designed to learn about the effects of Humira. Blinding was not performed to all studies. Few studies such as studies on malignancies, drug adverse reaction studies, crohn’s disease studies and plaque-psoriasis were open-labelled clinical trials.
e.2. Clinical outcome(s) measures (other than PRO)
More than 75% of patients improved their PASI score in plaque soriasis. Additionally, in extension of previous work that targeted on rheumatism, Erik H. Vogelzang, MD, from the Department of medical specialty, van Breemen analysis Institute, Reade, Amsterdam, European nation, and colleagues investigated the relationships among adalimumab concentrations, presence of ADA, and clinical response in 103 consecutive patients with PSA over the course of twenty eight and fifty two weeks of follow-up. The first outcome live within the prospective cohort study was unwellness Activity Score of twenty eight joints (DAS28). The researchers additionally measured blood corpuscle sed rate, C-reactive protein, and skin disorder space and Severity Index. They used enzyme-linked immunosorbent assay to live adalimumab concentrations and immunochemical assay to observe ADA in liquid body substance trough samples.
The researchers found that patients with detectable ADA had considerably lower adalimumab concentrations than patients while not detectable ADA. Adalimumab levels for patients with vs those while not ADA were one.3 vs 8.7 mg/L at week twenty eight (P < .001) and 0.9 vs 9.4 mg/L at week fifty two (P = .0001).
DAS28 for patients with PSA with vs while not ADA were a pair of.16 vs 2.95 at twenty eight weeks (P = .023) and 2.19 vs 2.95 at fifty two weeks (P = .024).
The researchers additionally found that median adalimumab concentration for patients receiving adalimumab monotherapy was considerably under for patients exploitation adalimumab and concomitant antimetabolite (MTX) at each twenty eight and fifty two weeks.
Finally, the researchers used a concentration/effect curve to spot Associate in Nursing best concentration vary for adalimumab, that was five to eight mg/L. curiously, forty seventh of patients within the study had adalimumab concentrations on top of this level; the authors recommend adalimumab dose may most likely be tapered in patients with low unwellness activity and high adalimumab concentrations.
e.3. Type of PRO included in the label: quality of life, satisfaction, preference for treatment, etc.
Quality of life is the PRO indicated in the label for Humira
e.4. Description of the PRO claim
Patient Related Outcome is essential for the drug approval and licensing. This claim enlists the patient name, insurer’s id, patient’s DOB, Address, Insurer name, patient’s economic condition, Name of the referrer, name of the refereeing physician, nature of illness or injury for the patient, date of service, procedures, Diagnosis pointer, Total charge, Patient Account details, tax id and finally signature of the billing provider is in the PRO claim. (Stahl)
e.5. PRO measures (instruments used to evaluate the PRO)
PROMIS instruments are available for all age in the assessment centre of NIH. It is easily downloadable and filled.
e.6. Statistical significance of outcomes and power calculations related to the PRO claim (if available)
All the clinical trials results are significant for C.I 95% p<0.05.
The evaluation of the warning letter will include the following information:a) Company, generic, brand name and therapeutic class of the product
Brand name: HUMIRA
Generic name: adalimumab
Therapeutic class of the product: Antirheumatic
b) AHFS or other Drug Classification
AHFS: 92.00
c) FDA Approved Indication
Humira got FDA approval in the year 2002
d) Identity the type of health economic claim included in marketing materials (cost, cost-effectiveness, price comparison, etc).
The cost of the product and price comparison between two similar drugs can be found.
e) Description of the warning lettere.1. Reasons of the warning letter (include a brief description of the issues identified by the FDA)
The reasons for the warning are the inclusion of Dear Doctor letter and misappropriation of professional labelling of Monodox drug by Oclassen Pharmacueticals. The company issued a false claim for low cost than other drug Minocycline. Moreover dear doctor letter has much false information about the adverse effects to CNS such as hypertension, head ache.
e.2. Health economic claim (Nolan and Mock)
The following claims have been stated in the warning letter. Claims that misrepresent the approved indications, safety claims and cost claim.e.3. Concern described by the FDA
FDA advices the company to stop the use of such promotional materials for marketing of the drug and also advices to provide DDMAC in written format of stopping the use. e.4. Proposed FDA actionf) Proposed a plan to correct the action, including the type of studies that would be required to support the marketing health economic claimFDA must charge criminal offense the drug manufacturers who indulge themselves in such case of misappropriations. According to the works from Neumann et al (1996), FDA must work with caution as well as flexibility with the drug manufacturers. It must stress the importance of pharmocogenic information about the specific drug. ".economic data has ne'er been thought of expressly by the FDA. However the growing use of pharmacoeconomics by drug makers and also the FDA’s sweeping mandate to manage advertising and labelling have forced the agency to appraise economic information formally. Though the FDA has an obligation to protect society from dishonest subject matter, it conjointly includes a responsibility to not impede the flow of probably helpful data. There is a desire for caution and adaptability on the part of the agency. As is commonly the case, the correct question isn't whether or not laws are necessary, however what level is affordable.
FDA policy ought to acknowledge the utility of cost-effectiveness information on a range of forms serving to decision makers to make clinical and resource allocation selections. Since selections can (and must) be created, it is sensible to avail ourselves of the maximum amount information as attainable, but imperfect. There square measure compelling reasons to believe that data regarding the cost-effectiveness of new prescribed drugs mustn't be command to constant standards of evidence as square measure the protection and effectualness of prescribed drugs. But there is also a desire for additional rigorous analysis. This would possibly come back from independent, private-sector evaluators WHO answer market demands for prompt and reliable data.
Works cited
Neumann P J, Zinner D E and Paltiel A D. “The FDA and regulation of cost-effectiveness claims”, Health Affairs, 15, no.3 (1996):54-71
Nolan, Marie T, and Victoria Mock. Measuring Patient Outcomes. 1st ed. Thousand Oaks, Calif.: Sage Publications, 2000. Print.
Stahl, Michael J. Encyclopedia Of Health Care Management. 1st ed. Thousand Oaks, Calif.: Sage Publications, 2004. Print.
