4 ms·

This isn't typically true -- If a doctor writes a Rx for Lipitor, it'll almost never be filled with the Brand Name Lipitor. All insurance and most formularies e

This isn't typically true -- If a doctor writes a Rx for Lipitor, it'll almost never be filled with the Brand Name Lipitor. All insurance and most formularies expect that the generic will be provided. Doctors have to write "DAW" or "Dispense as Written" on the Rx for the patient to receive the brand name when a generic is available. AJM Confirming that all states have Generic Substitution laws to lower drug costs: https://www.amjmed.com/article/S0002-9343(10)01087-9/abstract https://www.amjmed.com/article/S0002-9343(10)01087-9/abstrac...

delecti 8y ago
Every prescription I've received in the last several years had two signature lines. If the doctor signs on one, it's "dispense as written", and if they sign the other it's "substitution permitted". So it's not like they have to do something special to get DAW.
- mikeyouse 8y ago
  But how many of the prescriptions you received had the signature on the DAW line? It's typically very uncommon. In fact, in the hospital setting, a portion of a Physician's reimbursement is tied to the ratio of generics to brand name drugs that their patients were given. I'm not sure if this is the case for outpatient stuff, but internists are absolutely incentivized to prescribe generics.
  - delecti 8y ago
    None, but that's not the point. I was just saying that there's not an extra hurdle to prescribe DAW like you were implying.
mjcl 8y ago
But to date, delivery devices like the adrenaclick have not been considered equivalent to epipen. Some states permit a substitution in these cases (a 'BX' rating instead of 'AB'), but many do not allow it without getting clarification from the prescriber.
- chimeracoder 8y ago
  > But to date, delivery devices like the adrenaclick have not been considered equivalent to epipen. Some states permit a substitution in these cases (a 'BX' rating instead of 'AB'), but many do not allow it without getting clarification from the prescriber. Because, unlike the generic version described in the original article, none of those were generic versions of the EpiPen. They were alternate delivery systems.
  - maxerickson 8y ago
    Some of the ones pulled in 2007 or 2008 were generic versions of the EpiPen that existed at the time.
MBCook 8y ago
But you can only do that if the FDA has said the generic is a perfect substitute, which hasn’t happened on any previous substitutes. This device is the first one to get that label.
- refurb 8y ago
  Correct, a drug has to be listed as "AB rated" in the FDA Orange book in order to be substituted automatically for the branded version.[1] AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements Andrenaclick is "BX rated".[2] BX Drug products for which the data are insufficient to determine therapeutic equivalence The new generic version from Teva is "AB rated".[3] [1]https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm#tecode https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm0790... [2]https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=020800 https://www.accessdata.fda.gov/scripts/cder/ob/results_produ... [3]https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=090589 https://www.accessdata.fda.gov/scripts/cder/ob/results_produ...
dboreham 8y ago
This is the whole point of the article btw : there have been "non-Mylan" EpiPen products on the market in the US for the past year (that are low cost) but they aren't magically associated with the SKU "EpiPen" in the Pharmacy -- you have request them by name. This news is about an alternative autoinjector being approved for that special "Pharmacist can substitute for the real thing regardless" status. Source : son with severe peanut allergy and insurance that doesn't cover epipens. Made several trips to Canada (for other reasons); bought Epipens there for us and various friends.
wutbrodo 8y ago
As I understand, Epipens have a specific legal exception to this law. Epipen prescriptions are not valid for, say, adrenaclick injectors.
InclinedPlane 8y ago
A pill is just a pill, and the FDA accepts many generic drugs as substitutes for the name brand version. But an epipen is not just an epinephrine injector it is, itself, a medical device, and until now your prescription for an "epipen" wouldn't allow you to get a substitute device. Consider the scenarios here. How would someone get a prescription for a non "EpiPen" epinephrine injector? They would have to be very savvy with access to a doctor as well as incredibly price conscious. They would have to convince their doctor to write a prescription for a specific other device. All of which is a very unlikely chain of events.

delecti 8y ago

Every prescription I've received in the last several years had two signature lines. If the doctor signs on one, it's "dispense as written", and if they sign the other it's "substitution permitted". So it's not like they have to do something special to get DAW.

mikeyouse 8y ago
But how many of the prescriptions you received had the signature on the DAW line? It's typically very uncommon. In fact, in the hospital setting, a portion of a Physician's reimbursement is tied to the ratio of generics to brand name drugs that their patients were given. I'm not sure if this is the case for outpatient stuff, but internists are absolutely incentivized to prescribe generics.
- delecti 8y ago
  None, but that's not the point. I was just saying that there's not an extra hurdle to prescribe DAW like you were implying.

mjcl 8y ago

But to date, delivery devices like the adrenaclick have not been considered equivalent to epipen. Some states permit a substitution in these cases (a 'BX' rating instead of 'AB'), but many do not allow it without getting clarification from the prescriber.

chimeracoder 8y ago
> But to date, delivery devices like the adrenaclick have not been considered equivalent to epipen. Some states permit a substitution in these cases (a 'BX' rating instead of 'AB'), but many do not allow it without getting clarification from the prescriber. Because, unlike the generic version described in the original article, none of those were generic versions of the EpiPen. They were alternate delivery systems.
- maxerickson 8y ago
  Some of the ones pulled in 2007 or 2008 were generic versions of the EpiPen that existed at the time.

MBCook 8y ago

But you can only do that if the FDA has said the generic is a perfect substitute, which hasn’t happened on any previous substitutes. This device is the first one to get that label.

refurb 8y ago
Correct, a drug has to be listed as "AB rated" in the FDA Orange book in order to be substituted automatically for the branded version.[1] AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements Andrenaclick is "BX rated".[2] BX Drug products for which the data are insufficient to determine therapeutic equivalence The new generic version from Teva is "AB rated".[3] [1]https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm#tecode https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm0790... [2]https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=020800 https://www.accessdata.fda.gov/scripts/cder/ob/results_produ... [3]https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=090589 https://www.accessdata.fda.gov/scripts/cder/ob/results_produ...

dboreham 8y ago

This is the whole point of the article btw : there have been "non-Mylan" EpiPen products on the market in the US for the past year (that are low cost) but they aren't magically associated with the SKU "EpiPen" in the Pharmacy -- you have request them by name. This news is about an alternative autoinjector being approved for that special "Pharmacist can substitute for the real thing regardless" status. Source : son with severe peanut allergy and insurance that doesn't cover epipens. Made several trips to Canada (for other reasons); bought Epipens there for us and various friends.

wutbrodo 8y ago

As I understand, Epipens have a specific legal exception to this law. Epipen prescriptions are not valid for, say, adrenaclick injectors.

InclinedPlane 8y ago

A pill is just a pill, and the FDA accepts many generic drugs as substitutes for the name brand version. But an epipen is not just an epinephrine injector it is, itself, a medical device, and until now your prescription for an "epipen" wouldn't allow you to get a substitute device. Consider the scenarios here. How would someone get a prescription for a non "EpiPen" epinephrine injector? They would have to be very savvy with access to a doctor as well as incredibly price conscious. They would have to convince their doctor to write a prescription for a specific other device. All of which is a very unlikely chain of events.